Trial Outcomes & Findings for A Study to Evaluate Safety, PK and Efficacy of HS-10296 in Patients With NSCLC (NCT NCT02981108)
NCT ID: NCT02981108
Last Updated: 2023-01-23
Results Overview
DLT is defined as one of the following HS-10296 related adverse event (AE) ：(1) Hematological toxicity ≥ Grade 4 neutropenia lasting more than 5 days, febrile neutropenia of any duration (absolute neutrophil count \[ANC\]) \< 1.0 × 109/L and fever ≥ 38.5°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with bleeding, any requirement for platelet transfusion, Grade 4 anemia (unexplained by underlying disease); (2)Non-hematological toxicity ≥ CTCAE Grade 3 including Infection (including febrile neutropenia), confirmed prolongation of QT interval corrected with Fridericia's (QTcF) (\> 500 ms absolute or \> 60 ms above Baseline) and cardiac toxicity greater than Grade 3；(3)Any other toxicity that is greater than that at Baseline (clinically significant and/or unacceptable, and judged to be a DLT by the SRC), meets a protocol-defined stopping criteria (i.e., confirmed corneal ulceration), or results in a disruption of dosing schedule of more than 7 days.
Recruitment status
UNKNOWN
Study phase
PHASE1/PHASE2
Target enrollment
364 participants
Primary outcome timeframe
21 days
Results posted on
2023-01-23
Participant Flow
A total of 364 patients were enrolled at 47 centers in 2 countries.
Participant milestones
| Measure |
Escalation Cohort 1
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 2
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 3
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 4
Oral Once-Daily Administration of HS-10296 260mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 1
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 2
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 3
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Phase 2 Extension
Oral Once-Daily Administration of HS-10296 (MTD or RP2D)
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
8
|
6
|
30
|
33
|
31
|
244
|
|
Overall Study
COMPLETED
|
5
|
6
|
7
|
6
|
21
|
15
|
13
|
62
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
9
|
18
|
18
|
182
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Safety, PK and Efficacy of HS-10296 in Patients With NSCLC
Baseline characteristics by cohort
| Measure |
Escalation Cohort 1
n=6 Participants
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 2
n=6 Participants
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 3
n=8 Participants
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 4
n=6 Participants
Oral Once-Daily Administration of HS-10296 260mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 1
n=30 Participants
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 2
n=33 Participants
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 3
n=31 Participants
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Phase 2 Extension
n=244 Participants
Oral Once-Daily Administration of HS-10296 (MTD or RP2D)
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Total
n=364 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
153 Participants
n=24 Participants
|
228 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
91 Participants
n=24 Participants
|
136 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
142 Participants
n=24 Participants
|
219 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
102 Participants
n=24 Participants
|
145 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
31 Participants
n=8 Participants
|
244 Participants
n=24 Participants
|
358 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
2 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
7 participants
n=42 Participants
|
|
Region of Enrollment
Taiwan
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
5 participants
n=4 Participants
|
13 participants
n=21 Participants
|
17 participants
n=8 Participants
|
18 participants
n=8 Participants
|
55 participants
n=24 Participants
|
124 participants
n=42 Participants
|
|
Region of Enrollment
China
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
16 participants
n=21 Participants
|
14 participants
n=8 Participants
|
13 participants
n=8 Participants
|
189 participants
n=24 Participants
|
233 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 21 daysDLT is defined as one of the following HS-10296 related adverse event (AE) ：(1) Hematological toxicity ≥ Grade 4 neutropenia lasting more than 5 days, febrile neutropenia of any duration (absolute neutrophil count \[ANC\]) \< 1.0 × 109/L and fever ≥ 38.5°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with bleeding, any requirement for platelet transfusion, Grade 4 anemia (unexplained by underlying disease); (2)Non-hematological toxicity ≥ CTCAE Grade 3 including Infection (including febrile neutropenia), confirmed prolongation of QT interval corrected with Fridericia's (QTcF) (\> 500 ms absolute or \> 60 ms above Baseline) and cardiac toxicity greater than Grade 3；(3)Any other toxicity that is greater than that at Baseline (clinically significant and/or unacceptable, and judged to be a DLT by the SRC), meets a protocol-defined stopping criteria (i.e., confirmed corneal ulceration), or results in a disruption of dosing schedule of more than 7 days.
Outcome measures
| Measure |
Escalation Cohort 1
n=6 Participants
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 2
n=6 Participants
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 3
n=8 Participants
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 4
n=6 Participants
Oral Once-Daily Administration of HS-10296 260mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 1
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 2
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 3
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Phase 2 Extension
Oral Once-Daily Administration of HS-10296 110mg (RP2D)
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicity (DLT) Phase I Part
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the date of first dose until the date of disease progression or withdrawal from study, approximately 15 monthsORR is defined as the percentage of patients with a complete response (CR) or partial response (PR) that was confirmed at a subsequent scan at least 6 weeks later, as assessed according to RECIST (Response Evaluation Criteria In Solid Tumors Criteria) version 1.1 for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Escalation Cohort 1
n=244 Participants
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 2
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 3
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 4
Oral Once-Daily Administration of HS-10296 260mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 1
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 2
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 3
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Phase 2 Extension
Oral Once-Daily Administration of HS-10296 110mg (RP2D)
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) Phase II Part
|
65.6 percentage of participants
Interval 59.2 to 71.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the screening period to 28 days after treatment completion, approximately 16 monthsAn AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition can be symptoms (e.g., nausea, chest pain), signs (e.g., tachycardia, enlarged liver), or the abnormal results of an investigation (e.g., laboratory findings, ECG). Any deterioration of the disease under study and associated symptoms or findings should not be regarded as an AE as far as the deterioration can be anticipated. The AE was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
Outcome measures
| Measure |
Escalation Cohort 1
n=6 Participants
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 2
n=6 Participants
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 3
n=8 Participants
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 4
n=6 Participants
Oral Once-Daily Administration of HS-10296 260mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 1
n=30 Participants
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 2
n=33 Participants
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 3
n=31 Participants
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Phase 2 Extension
Oral Once-Daily Administration of HS-10296 110mg (RP2D)
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
|---|---|---|---|---|---|---|---|---|
|
Incidence and Severity of Adverse Events (AEs) Phase I Part
At least one adverse event
|
6 Participants
|
6 Participants
|
8 Participants
|
6 Participants
|
30 Participants
|
32 Participants
|
31 Participants
|
—
|
|
Incidence and Severity of Adverse Events (AEs) Phase I Part
At least one adverse event of Grade 3 or greater
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
8 Participants
|
11 Participants
|
—
|
|
Incidence and Severity of Adverse Events (AEs) Phase I Part
At least one serious adverse event
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: From pre-dose to 24 hours after single dose on Day 1 of Cycle 0Population: Data was collected for only Part 1 dose escalation Arms
Area under the plasma concentration versus time curve from time zero to the 24-hour sampling time at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-24 was to be calculated according to the mixed log-linear trapezoidal rule.
Outcome measures
| Measure |
Escalation Cohort 1
n=6 Participants
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 2
n=6 Participants
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 3
n=8 Participants
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 4
n=6 Participants
Oral Once-Daily Administration of HS-10296 260mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 1
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 2
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 3
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Phase 2 Extension
Oral Once-Daily Administration of HS-10296 110mg (RP2D)
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) of HS-10296 and HAS-719 From Zero to the 24-Hour Sampling Time (AUC0-24) After Single Dose of HS-10296
HS-10296
|
1740.1175 h*ng/mL
Standard Deviation 917.7303
|
5250.2364 h*ng/mL
Standard Deviation 3345.8348
|
8174.4312 h*ng/mL
Standard Deviation 8126.7012
|
8038.9348 h*ng/mL
Standard Deviation 1648.4566
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) of HS-10296 and HAS-719 From Zero to the 24-Hour Sampling Time (AUC0-24) After Single Dose of HS-10296
HAS-719
|
298.4934 h*ng/mL
Standard Deviation 131.6189
|
696.4536 h*ng/mL
Standard Deviation 293.4756
|
1152.1150 h*ng/mL
Standard Deviation 475.5067
|
1564.3829 h*ng/mL
Standard Deviation 488.6330
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From pre-dose to 120 hours after single dose on Day 1 of Cycle 0Population: Data was collected for only Part 1 dose escalation Arms
Elimination half-life is the time measured for the concentration to decrease by one half. Half-life calculated by natural log 2 divided by λz.
Outcome measures
| Measure |
Escalation Cohort 1
n=6 Participants
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 2
n=6 Participants
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 3
n=8 Participants
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 4
n=6 Participants
Oral Once-Daily Administration of HS-10296 260mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 1
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 2
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 3
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Phase 2 Extension
Oral Once-Daily Administration of HS-10296 110mg (RP2D)
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
|---|---|---|---|---|---|---|---|---|
|
Elimination Half-life(T1/2) of HS-10296 and HAS-719
HS-10296
|
31.29 hours
Standard Deviation 9.57
|
30.62 hours
Standard Deviation 9.34
|
35.19 hours
Standard Deviation 13.89
|
34.81 hours
Standard Deviation 9.76
|
—
|
—
|
—
|
—
|
|
Elimination Half-life(T1/2) of HS-10296 and HAS-719
HAS-719
|
49.75 hours
Standard Deviation 10.70
|
55.36 hours
Standard Deviation 19.95
|
63.75 hours
Standard Deviation 29.83
|
57.79 hours
Standard Deviation 13.95
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From pre-dose to 21 days after multiple dose on Day 1 of Cycle 2Observed maximum plasma concentration (Css max) after multiple dose of HS-10296 and HAS-719
Outcome measures
| Measure |
Escalation Cohort 1
n=6 Participants
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 2
n=6 Participants
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 3
n=8 Participants
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 4
n=6 Participants
Oral Once-Daily Administration of HS-10296 260mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 1
n=30 Participants
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 2
n=33 Participants
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 3
n=31 Participants
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Phase 2 Extension
n=244 Participants
Oral Once-Daily Administration of HS-10296 110mg (RP2D)
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
|---|---|---|---|---|---|---|---|---|
|
Css Max of HS-10296 and HAS-719 After Multiple Dose
HS-10296
|
164.5000 ng/mL
Standard Deviation 70.6222
|
352.8333 ng/mL
Standard Deviation 102.7062
|
762.0000 ng/mL
Standard Deviation 231.8888
|
765.4000 ng/mL
Standard Deviation 285.2802
|
197.9308 ng/mL
Standard Deviation 78.6513
|
413.2751 ng/mL
Standard Deviation 194.0200
|
552.0635 ng/mL
Standard Deviation 257.9572
|
352.5111 ng/mL
Standard Deviation 185.3279
|
|
Css Max of HS-10296 and HAS-719 After Multiple Dose
HAS-719
|
55.3500 ng/mL
Standard Deviation 18.1391
|
118.1333 ng/mL
Standard Deviation 26.9018
|
276.1667 ng/mL
Standard Deviation 42.9391
|
338.2000 ng/mL
Standard Deviation 119.3302
|
62.9535 ng/mL
Standard Deviation 21.4094
|
142.1545 ng/mL
Standard Deviation 49.4867
|
221.9404 ng/mL
Standard Deviation 83.6900
|
118.3758 ng/mL
Standard Deviation 43.3468
|
SECONDARY outcome
Timeframe: From pre-dose to 21 days after multiple dose on Day 1 of Cycle 2Area Under the Plasma Concentration Versus Time Curve at steady state (AUCss) of HS-10296 and HAS-719 after multiple dose of HS-10296
Outcome measures
| Measure |
Escalation Cohort 1
n=6 Participants
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 2
n=6 Participants
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 3
n=8 Participants
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 4
n=6 Participants
Oral Once-Daily Administration of HS-10296 260mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 1
n=30 Participants
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 2
n=33 Participants
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 3
n=31 Participants
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Phase 2 Extension
n=244 Participants
Oral Once-Daily Administration of HS-10296 110mg (RP2D)
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
|---|---|---|---|---|---|---|---|---|
|
AUCss of HS-10296 and HAS-719 After Multiple Dose of HS-10296
HS-10296
|
2488.0953 h*ng/mL
Standard Deviation 439.3443
|
7000.2498 h*ng/mL
Standard Deviation 2832.8180
|
11994.8801 h*ng/mL
Standard Deviation 3839.4164
|
14101.8608 h*ng/mL
Standard Deviation 5294.1409
|
3550.8674 h*ng/mL
Standard Deviation 1451.0173
|
7098.0738 h*ng/mL
Standard Deviation 2826.1228
|
10185.6761 h*ng/mL
Standard Deviation 4862.0070
|
6602.2491 h*ng/mL
Standard Deviation 3482.0499
|
|
AUCss of HS-10296 and HAS-719 After Multiple Dose of HS-10296
HAS-719
|
983.7103 h*ng/mL
Standard Deviation 201.9267
|
2691.7220 h*ng/mL
Standard Deviation 677.2407
|
5458.2304 h*ng/mL
Standard Deviation 659.3078
|
8154.0849 h*ng/mL
Standard Deviation 1144.0617
|
1304.4143 h*ng/mL
Standard Deviation 429.1216
|
2852.8083 h*ng/mL
Standard Deviation 820.1842
|
4692.6023 h*ng/mL
Standard Deviation 1771.6881
|
2467.8527 h*ng/mL
Standard Deviation 892.5071
|
SECONDARY outcome
Timeframe: From the date of first dose until the date of disease progression or withdrawal from study, approximately 15 monthsORR is defined as the percentage of patients with a complete response (CR) or partial response (PR) that was confirmed at a subsequent scan at least 6 weeks later, as assessed according to RECIST (Response Evaluation Criteria In Solid Tumors Criteria) version 1.1 for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Escalation Cohort 1
n=6 Participants
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 2
n=6 Participants
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 3
n=8 Participants
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 4
n=6 Participants
Oral Once-Daily Administration of HS-10296 260mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 1
n=30 Participants
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 2
n=33 Participants
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 3
n=31 Participants
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Phase 2 Extension
Oral Once-Daily Administration of HS-10296 110mg (RP2D)
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate (Phase I Part)
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
66.7 percentage of participants
Interval 22.3 to 95.7
|
37.5 percentage of participants
Interval 8.5 to 75.5
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
60.0 percentage of participants
Interval 40.6 to 77.3
|
54.5 percentage of participants
Interval 36.4 to 71.9
|
41.9 percentage of participants
Interval 24.5 to 60.9
|
—
|
SECONDARY outcome
Timeframe: From the date of enrollment until the date of disease progression or death from any cause, approximately 15 monthsThe PFS is defined as the time from date of first dosing until the date of objective disease progression as defined by Response Evaluation Criteria in Solid Tumors （RECIST） v1.1 or death (by any cause in the absence of progression) regardless of whether the patients withdraws from HS-10296 therapy or receives another anti-cancer therapy prior to progression. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Escalation Cohort 1
n=6 Participants
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 2
n=6 Participants
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 3
n=8 Participants
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 4
n=6 Participants
Oral Once-Daily Administration of HS-10296 260mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 1
n=30 Participants
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 2
n=33 Participants
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 3
n=31 Participants
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Phase 2 Extension
n=244 Participants
Oral Once-Daily Administration of HS-10296 110mg (RP2D)
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
11.2 months
Interval 3.0 to
Since the curve that represents the upper confidence limits for the KM survivor function lies above 0.5, thus the upper limits for the median can not be estimated.
|
7.0 months
Interval 5.8 to 12.5
|
5.5 months
Interval 1.1 to 8.4
|
3.7 months
Interval 0.8 to 11.0
|
9.6 months
Interval 6.7 to 15.1
|
13.6 months
Interval 6.9 to 19.2
|
11.1 months
Interval 8.3 to 24.8
|
12.4 months
Interval 9.7 to 15.0
|
SECONDARY outcome
Timeframe: From the date of first dose until the date of disease progression or withdrawal from study, approximately 15 monthsObjective response is assessed by RECIST 1.1 thereby to evaluate disease control rate. The DCR is defined as the proportion of patients with a best overall response of CR, PR, or SD (stable disease).
Outcome measures
| Measure |
Escalation Cohort 1
n=6 Participants
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 2
n=6 Participants
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 3
n=8 Participants
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 4
n=6 Participants
Oral Once-Daily Administration of HS-10296 260mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 1
n=30 Participants
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 2
n=33 Participants
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 3
n=31 Participants
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Phase 2 Extension
n=244 Participants
Oral Once-Daily Administration of HS-10296 110mg (RP2D)
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR)
|
100.0 percentage of participants
Interval 54.1 to 100.0
|
100.0 percentage of participants
Interval 54.1 to 100.0
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
83.3 percentage of participants
Interval 65.3 to 94.4
|
97.0 percentage of participants
Interval 84.2 to 99.9
|
93.5 percentage of participants
Interval 78.6 to 99.2
|
93.4 percentage of participants
Interval 89.6 to 96.2
|
SECONDARY outcome
Timeframe: From the date of enrollment until the date of death from any cause, approximately 48 monthsOverall survival will be assessed based on the date of first dose and survival status at the time of analysis. Overall survival is defined as the time from date of first dose until the documentation of death from any cause.
Outcome measures
| Measure |
Escalation Cohort 1
n=244 Participants
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 2
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 3
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 4
Oral Once-Daily Administration of HS-10296 260mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 1
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 2
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 3
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Phase 2 Extension
Oral Once-Daily Administration of HS-10296 110mg (RP2D)
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) Phase II Part
|
31.5 months
Interval 25.9 to 35.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of enrollment until the date of disease progression or death, approximately 15 monthsPopulation: Based on the ICR evaluation results, DepOR analysis was performed on patients with efficacy evaluation
Depth of Response (DepOR) Only in part II dose-extention phase. DepOR is defined as the percentage change in tumor size, based on longest diameter or reconstructed volume, observed at the lowest point compared with baseline.
Outcome measures
| Measure |
Escalation Cohort 1
n=237 Participants
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 2
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 3
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 4
Oral Once-Daily Administration of HS-10296 260mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 1
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 2
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 3
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Phase 2 Extension
Oral Once-Daily Administration of HS-10296 110mg (RP2D)
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
|---|---|---|---|---|---|---|---|---|
|
Depth of Response (DepOR)
|
-47.89 percentage of change from baseline
Standard Deviation 22.333
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of enrollment until the date of disease progression or death, approximately 18 monthsDuration of response (DoR) is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression. The end of response should coincide with the date of progression or death from any cause used for the PFS endpoint. The time of the initial response will be defined as the latest of the dates contributing towards the first visit response of PR or CR. If a patient does not progress following a response, then DoR will be used as the PFS censoring time.
Outcome measures
| Measure |
Escalation Cohort 1
n=6 Participants
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 2
n=6 Participants
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 3
n=8 Participants
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 4
n=6 Participants
Oral Once-Daily Administration of HS-10296 260mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 1
n=30 Participants
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 2
n=33 Participants
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 3
n=31 Participants
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Phase 2 Extension
n=244 Participants
Oral Once-Daily Administration of HS-10296 110mg (RP2D)
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DoR)
|
13.9 months
Interval 1.9 to
Since the curve that represents the upper confidence limits for the KM survivor function lies above 0.5, thus the upper limits for the median can not be estimated.
|
5.6 months
Interval 4.2 to 9.5
|
5.6 months
Interval 4.1 to 7.0
|
5.5 months
Since the curve that represents the upper confidence limits for the KM survivor function lies above 0.5, thus the upper limits for the median can not be estimated.
|
8.3 months
Interval 8.1 to 16.5
|
12.5 months
Interval 5.5 to 22.1
|
22.1 months
Interval 8.1 to 35.7
|
15.1 months
Interval 12.9 to 16.6
|
SECONDARY outcome
Timeframe: From the screening period to 28 days after treatment completion, approximately 16 monthsAn AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition can be symptoms (e.g., nausea, chest pain), signs (e.g., tachycardia, enlarged liver), or the abnormal results of an investigation (e.g., laboratory findings, ECG). Any deterioration of the disease under study and associated symptoms or findings should not be regarded as an AE as far as the deterioration can be anticipated. The AE was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.
Outcome measures
| Measure |
Escalation Cohort 1
n=244 Participants
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 2
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 3
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 4
Oral Once-Daily Administration of HS-10296 260mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 1
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 2
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 3
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Phase 2 Extension
Oral Once-Daily Administration of HS-10296 110mg (RP2D)
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
|---|---|---|---|---|---|---|---|---|
|
Incidence and Severity of AEs Phase II Part
At least 1 adverse event
|
219 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence and Severity of AEs Phase II Part
At least one adverse event of Grade 3 or greater
|
60 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence and Severity of AEs Phase II Part
At least one serious adverse event
|
30 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Escalation Cohort 1
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Escalation Cohort 2
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Escalation Cohort 3
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Escalation Cohort 4
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Expansion Cohort 1
Serious events: 5 serious events
Other events: 29 other events
Deaths: 0 deaths
Expansion Cohort 2
Serious events: 6 serious events
Other events: 31 other events
Deaths: 0 deaths
Expansion Cohort 3
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
Phase 2 Extension
Serious events: 30 serious events
Other events: 193 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Escalation Cohort 1
n=6 participants at risk
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 2
n=6 participants at risk
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 3
n=8 participants at risk
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 4
n=6 participants at risk
Oral Once-Daily Administration of HS-10296 260mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 1
n=30 participants at risk
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 2
n=33 participants at risk
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 3
n=31 participants at risk
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Phase 2 Extension
n=244 participants at risk
Oral Once-Daily Administration of HS-10296 (MTD or RP2D)
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.3%
1/30 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.3%
1/30 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Pneumonitis
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
2.0%
5/244 • Number of events 5 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.0%
1/33 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Gastrointestinal disorders
Bowel obstruction
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
General disorders
Peripheral swelling
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.0%
1/33 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.3%
1/30 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.0%
1/33 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.0%
1/33 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Cystitis
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Empyema
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Herpes ophthalmic
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
—
0/0 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
General disorders
Chest discomfort
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
General disorders
Death
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
1.2%
3/244 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.3%
1/30 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.82%
2/244 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.3%
1/30 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.3%
8/244 • Number of events 8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.82%
2/244 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Vascular disorders
Embolism
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.82%
2/244 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.5%
2/31 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.82%
2/244 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Gastrointestinal disorders
Ileus
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.2%
1/31 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.3%
1/30 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.3%
1/30 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
1.2%
3/244 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.82%
2/244 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.2%
1/31 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.2%
1/31 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.3%
1/30 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.0%
1/33 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to breast
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.0%
1/33 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.41%
1/244 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
Other adverse events
| Measure |
Escalation Cohort 1
n=6 participants at risk
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 2
n=6 participants at risk
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 3
n=8 participants at risk
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Escalation Cohort 4
n=6 participants at risk
Oral Once-Daily Administration of HS-10296 260mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 1
n=30 participants at risk
Oral Once-Daily Administration of HS-10296 55mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 2
n=33 participants at risk
Oral Once-Daily Administration of HS-10296 110mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Expansion Cohort 3
n=31 participants at risk
Oral Once-Daily Administration of HS-10296 220mg
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
Phase 2 Extension
n=244 participants at risk
Oral Once-Daily Administration of HS-10296 (MTD or RP2D)
HS-10296: HS-10296: 5-, 10-, 40-, and 55-mg tablet, immediate-release formulation. Patients should avoid consumption of food for at least 1 hour prior to and 2 hours post dosing. RP2D is determined at 110 mg QD.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.7%
2/30 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.1%
2/33 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
33.3%
2/6 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
General disorders
Asthenia
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
General disorders
Chest pain
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
25.0%
2/8 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.7%
2/30 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.1%
4/33 • Number of events 4 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
9.7%
3/31 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
General disorders
Chills
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
25.0%
2/8 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
General disorders
Malaise
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.7%
2/30 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.2%
1/31 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.0%
1/33 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.5%
2/31 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.1%
2/33 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
9.7%
3/31 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
2.9%
7/244 • Number of events 7 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
General disorders
Pain
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
General disorders
Xerosis
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.5%
2/31 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
1.2%
3/244 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
25.0%
2/8 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.1%
4/33 • Number of events 4 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
4.5%
11/244 • Number of events 11 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.3%
1/30 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
9.7%
3/31 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
9.7%
3/31 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.7%
9/244 • Number of events 9 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Eye disorders
Dry eye
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
13.3%
4/30 • Number of events 4 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.1%
4/33 • Number of events 4 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.2%
1/31 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
2.9%
7/244 • Number of events 7 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Eye disorders
Glaucoma
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.7%
2/30 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.0%
1/33 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.2%
1/31 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.1%
2/33 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Eye disorders
Vision blurred
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.0%
1/33 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.5%
2/31 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
2.0%
5/244 • Number of events 5 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Eye disorders
Visual impairment
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.3%
1/30 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.5%
2/31 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
25.0%
2/8 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
33.3%
2/6 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
33.3%
2/6 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
37.5%
3/8 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
10.0%
3/30 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
9.1%
3/33 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.5%
2/31 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
8.2%
20/244 • Number of events 20 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
2/6 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
25.0%
2/8 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
10.0%
3/30 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
15.2%
5/33 • Number of events 5 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
22.6%
7/31 • Number of events 7 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
4.5%
11/244 • Number of events 11 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Gastrointestinal disorders
Mouth ulceration
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
10.0%
3/30 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.1%
2/33 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.5%
2/31 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
4.1%
10/244 • Number of events 10 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
25.0%
2/8 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
66.7%
4/6 • Number of events 4 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.1%
4/33 • Number of events 4 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.1%
5/31 • Number of events 5 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.1%
15/244 • Number of events 15 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.1%
2/33 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.9%
4/31 • Number of events 4 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Acute sinusitis
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
9.1%
3/33 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.2%
1/31 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Folliculitis
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Furuncle
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Helicobacter infection
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
25.0%
2/8 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Onychomycosis
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Paronychia
|
33.3%
2/6 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.3%
1/30 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.9%
4/31 • Number of events 4 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Tonsillitis
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
2/6 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
33.3%
2/6 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
20.0%
6/30 • Number of events 6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.1%
2/33 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
9.7%
3/31 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
13.1%
32/244 • Number of events 32 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
25.0%
2/8 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
13.3%
4/30 • Number of events 4 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.1%
2/33 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.1%
5/31 • Number of events 5 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
11.5%
28/244 • Number of events 28 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Investigations
Alpha hydroxybutyrate dehydrogenase increased
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.5%
2/31 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Investigations
Aspartate aminotransferase abnormal
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
25.0%
2/8 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
13.3%
4/30 • Number of events 4 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.1%
2/33 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
22.6%
7/31 • Number of events 7 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
13.5%
33/244 • Number of events 33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Investigations
Blood creatine phosphokinase MB increased
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.5%
2/31 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
10.0%
3/30 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.5%
2/31 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
4.9%
12/244 • Number of events 12 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
9.7%
3/31 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Investigations
Blood urea increased
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.3%
1/30 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.0%
1/33 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.5%
2/31 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.3%
1/30 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.0%
1/33 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
9.7%
3/31 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
4.5%
11/244 • Number of events 11 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Investigations
Myoglobin blood increased
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.5%
2/31 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
25.0%
2/8 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
5/30 • Number of events 5 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
9.1%
3/33 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
5.7%
14/244 • Number of events 14 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Investigations
Neutrophil percentage increased
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.7%
2/30 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Investigations
Weight decreased
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
13.3%
4/30 • Number of events 4 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
9.7%
3/31 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Investigations
Weight increased
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.3%
1/30 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.1%
2/33 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.2%
1/31 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
4.1%
10/244 • Number of events 10 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Investigations
White blood cell count decreased
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
23.3%
7/30 • Number of events 7 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.1%
2/33 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.5%
2/31 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
9.4%
23/244 • Number of events 23 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.7%
2/30 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.2%
1/31 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.7%
2/30 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.2%
1/31 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
4.5%
11/244 • Number of events 11 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.0%
1/33 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
9.7%
3/31 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.5%
2/31 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
4.1%
10/244 • Number of events 10 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.7%
2/30 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
9.1%
3/33 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
9.7%
3/31 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
4.1%
10/244 • Number of events 10 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.3%
1/30 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
9.7%
3/31 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
2.9%
7/244 • Number of events 7 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
2/6 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
10.0%
3/30 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
9.1%
3/33 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
25.8%
8/31 • Number of events 8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
25.0%
2/8 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.3%
1/30 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.1%
2/33 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.5%
2/31 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Nervous system disorders
Muscle spasticity
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Renal and urinary disorders
Haematuria
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.7%
2/30 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.1%
2/33 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.5%
2/31 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.9%
4/31 • Number of events 4 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
7.0%
17/244 • Number of events 17 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
33.3%
2/6 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
20.0%
6/30 • Number of events 6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.1%
4/33 • Number of events 4 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
22.6%
7/31 • Number of events 7 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
10.2%
25/244 • Number of events 25 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.3%
1/30 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.5%
2/31 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.1%
2/33 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.2%
1/31 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.3%
1/30 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.0%
1/33 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.5%
2/31 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
1.6%
4/244 • Number of events 4 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.7%
2/30 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
9.7%
3/31 • Number of events 3 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.1%
2/33 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
25.0%
2/8 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.3%
1/30 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
18.2%
6/33 • Number of events 6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.9%
4/31 • Number of events 4 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
11.5%
28/244 • Number of events 28 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.7%
2/30 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
33.3%
2/6 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
5/30 • Number of events 5 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
18.2%
6/33 • Number of events 6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
19.4%
6/31 • Number of events 6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.3%
30/244 • Number of events 30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.7%
2/30 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.1%
2/33 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
3.2%
1/31 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.9%
4/31 • Number of events 4 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
2.5%
6/244 • Number of events 6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
12.5%
1/8 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
6.7%
2/30 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
25.0%
2/8 • Number of events 2 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
16.7%
1/6 • Number of events 1 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/8 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/6 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/30 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/33 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/31 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
0.00%
0/244 • Throughout the study, from informed consent until the end of the follow-up period. The follow-up period is defined as 28 ± 3 days after study treatment is discontinued, assessed up to 16 months. Deaths were assessed up to 48 months. Serious and Other (Non-Serious) Adverse Events were assessed up to 16 months.
|
Additional Information
Alison Li
Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
Phone: 86-21-51211850
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place