Trial Outcomes & Findings for Phase IIa Study Evaluating Safety and Efficacy of BL-8040 in Relapsed/Refractory AML Patients (NCT NCT01838395)
NCT ID: NCT01838395
Last Updated: 2024-09-19
Results Overview
Number of participants with Adverse event affecting the safety and tolerability of BL-8040 + Ara-C by dose level (overall, dose limiting events, related Adverse Events (AEs), Serious Adverse Events (SAEs), related SAEs, AE by severity and death) Toxicity grade was assessed according to version V4.03 of NCI-CTCAE
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
Participants were followed for the duration of the hospital stay and the follow-up period, an expected average of 6 weeks.
Results posted on
2024-09-19
Participant Flow
The study included 6 escalating dose groups The decision to proceed to the next dose level was made by an independent Data Monitoring Committee (DMC) after review of the relevant safety data. At the discretion of the Sponsor, additional subjects could be enrolled into a selected dose group to confirm the safety, efficacy and pharmacokinetic (PK) profile for the selected dose.
Participant milestones
| Measure |
Period 1: BL-8040 0.5 mg/kg + Ara-C
Participants were dosed with SC injections of 0.5 mg/kg BL-8040 over two days followed by concurrent administration of 0.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 2: BL-8040 0.75 mg/kg + Ara-C
Participants were dosed with SC injections of 0.75 mg/kg BL-8040 over two days followed by concurrent administration of 0.75 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 3: BL-8040 1.0 mg/kg + Ara-C
Participants were dosed with SC injections of 1.0 mg/kg BL-8040 over two days followed by concurrent administration of 1.0 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 4: BL-8040 1.25 mg/kg + Ara-C
Participants were dosed with SC injections of 1.25 mg/kg BL-8040 over two days followed by concurrent administration of 1.25 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 5 & Expansion Phase: BL-8040 1.5 mg/kg + Ara-C
Participants were dosed with SC injections of 1.5 mg/kg BL-8040 over two days followed by concurrent administration of 1.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 6: BL-8040 2.0 mg/kg + Ara-C
Participants were dosed with SC injections of 2.0 mg/kg BL-8040 over two days followed by concurrent administration of 2.0 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
4
|
23
|
3
|
|
Overall Study
COMPLETED
|
3
|
2
|
5
|
4
|
22
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Period 1: BL-8040 0.5 mg/kg + Ara-C
Participants were dosed with SC injections of 0.5 mg/kg BL-8040 over two days followed by concurrent administration of 0.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 2: BL-8040 0.75 mg/kg + Ara-C
Participants were dosed with SC injections of 0.75 mg/kg BL-8040 over two days followed by concurrent administration of 0.75 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 3: BL-8040 1.0 mg/kg + Ara-C
Participants were dosed with SC injections of 1.0 mg/kg BL-8040 over two days followed by concurrent administration of 1.0 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 4: BL-8040 1.25 mg/kg + Ara-C
Participants were dosed with SC injections of 1.25 mg/kg BL-8040 over two days followed by concurrent administration of 1.25 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 5 & Expansion Phase: BL-8040 1.5 mg/kg + Ara-C
Participants were dosed with SC injections of 1.5 mg/kg BL-8040 over two days followed by concurrent administration of 1.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 6: BL-8040 2.0 mg/kg + Ara-C
Participants were dosed with SC injections of 2.0 mg/kg BL-8040 over two days followed by concurrent administration of 2.0 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
started conditioning regimen prior to hematopoietic stem cell transplant
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Phase IIa Study Evaluating Safety and Efficacy of BL-8040 in Relapsed/Refractory AML Patients
Baseline characteristics by cohort
| Measure |
Period 1: 0.5 mg/kg BL-8040 + Ara-C
n=3 Participants
0.5 mg/kg BL-8040 administration over two days followed by concurrent administration of 0.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 2: 0.75 mg/kg BL-8040 + Ara-C
n=3 Participants
0.75 mg/kg BL-8040 administration over two days followed by concurrent administration of 0.75 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 3: 1.0 mg/kg BL-8040 + Ara-C
n=6 Participants
1.0 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.0 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 4: 1.25 mg/kg BL-8040 + Ara-C
n=4 Participants
1.25 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.25 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 5 & Expansion Phase: 1.5 mg/kg BL-8040 + Ara-C
n=23 Participants
1.5 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 6: 2.0 mg/kg BL-8040 + Ara-C
n=3 Participants
2.0 mg/kg BL-8040 administration over two days followed by concurrent administration of 2.0 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
62.0 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
56.8 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
62.3 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
61.3 years
STANDARD_DEVIATION 8.8 • n=21 Participants
|
52.3 years
STANDARD_DEVIATION 20.0 • n=8 Participants
|
60.2 years
STANDARD_DEVIATION 9.9 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
23 Participants
n=8 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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
38 Participants
n=8 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
|
|
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
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Participants were followed for the duration of the hospital stay and the follow-up period, an expected average of 6 weeks.Population: All patients who received at least one dose of BL-8040 were included in the analysis (ITT)
Number of participants with Adverse event affecting the safety and tolerability of BL-8040 + Ara-C by dose level (overall, dose limiting events, related Adverse Events (AEs), Serious Adverse Events (SAEs), related SAEs, AE by severity and death) Toxicity grade was assessed according to version V4.03 of NCI-CTCAE
Outcome measures
| Measure |
BL-8040 + Ara-C
n=42 Participants
Eligible subjects received subcutaneous (SC) injections of BL-8040 ("monotherapy period") over two days (one injection per day) followed by concurrent administration of BL-8040 with standard salvage chemotherapy ("combined period") over 5 days. During the "combined period," BL-8040 was be administered 4 hours prior to chemotherapy. The chemotherapy consisted of cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age), administered intravenously (IV) over 3 hours, for 5 days without escalation.
Ara-C: IV
BL-8040: SC
|
Period 1: BL-8040 0.5 mg/kg + Ara-C
n=3 Participants
0.5 mg/kg BL-8040 administration over two days followed by concurrent administration of 0.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 2: BL-8040 0.75 mg/kg + Ara-C
n=3 Participants
0.75 mg/kg BL-8040 administration over two days followed by concurrent administration of 0.75 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days
|
Period 3: BL-8040 1.0 mg/kg + Ara-C
n=6 Participants
1.0 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.0 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 4: BL-8040 1.25 mg/kg + Ara-C
n=4 Participants
1.25 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.25 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 5 & Expansion: BL-8040 1.5 mg/kg + Ara-C
n=23 Participants
1.5 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 6: BL-8040 2.0 mg/kg + Ara-C
n=3 Participants
2.0 mg/kg BL-8040 administration over two days followed by concurrent administration of 2.0 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
|---|---|---|---|---|---|---|---|
|
Safety and Tolerability
Adverse event: Subjects with any adverse event (per patient)
|
42 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
23 Participants
|
3 Participants
|
|
Safety and Tolerability
Adverse event: Subjects with any dose-limiting event (per patient)
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Safety and Tolerability
Adverse event: Subjects with any drug-related AE (Definite/Probable)
|
35 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
20 Participants
|
3 Participants
|
|
Safety and Tolerability
Adverse event: Subjects with any drug-related AE (Definite/Probable/Possible)
|
40 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
23 Participants
|
3 Participants
|
|
Safety and Tolerability
Adverse event: Subjects with any serious AE
|
21 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
10 Participants
|
3 Participants
|
|
Safety and Tolerability
Adverse event: Subjects with any serious AE also drug-related (Definite/Probable)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety and Tolerability
Adverse event: Subjects with serious AE also drug-related (Definite/Probable/Possible)
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Safety and Tolerability
Adverse event : Subjects with severe or life-threatening AE
|
33 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
19 Participants
|
3 Participants
|
|
Safety and Tolerability
Adverse event : Subjects with mild and/or moderate AE
|
41 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
22 Participants
|
3 Participants
|
|
Safety and Tolerability
Adverse event : Death
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Final bone marrow evaluation - Between Day 20 and Day 44Response rate as assessed at final bone marrow evaluation based on Cheson et al 2003 criteria. * CR defined as bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0 x 10\^9/L (1000/μL); platelet count \>100 x 10\^9/L (100,000/μL); independent of red cell transfusions * CRi defined as all CR criteria except for residual neutropenia (\<1.0 x 10\^9/L \[1000/μL\]) or thrombocytopenia (\<100 x 10\^9/L \[100,000/μL\]) * Partial Response (PR) defined as all hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%
Outcome measures
| Measure |
BL-8040 + Ara-C
n=3 Participants
Eligible subjects received subcutaneous (SC) injections of BL-8040 ("monotherapy period") over two days (one injection per day) followed by concurrent administration of BL-8040 with standard salvage chemotherapy ("combined period") over 5 days. During the "combined period," BL-8040 was be administered 4 hours prior to chemotherapy. The chemotherapy consisted of cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age), administered intravenously (IV) over 3 hours, for 5 days without escalation.
Ara-C: IV
BL-8040: SC
|
Period 1: BL-8040 0.5 mg/kg + Ara-C
n=3 Participants
0.5 mg/kg BL-8040 administration over two days followed by concurrent administration of 0.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 2: BL-8040 0.75 mg/kg + Ara-C
n=6 Participants
0.75 mg/kg BL-8040 administration over two days followed by concurrent administration of 0.75 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days
|
Period 3: BL-8040 1.0 mg/kg + Ara-C
n=4 Participants
1.0 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.0 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 4: BL-8040 1.25 mg/kg + Ara-C
n=23 Participants
1.25 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.25 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 5 & Expansion: BL-8040 1.5 mg/kg + Ara-C
n=3 Participants
1.5 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 6: BL-8040 2.0 mg/kg + Ara-C
2.0 mg/kg BL-8040 administration over two days followed by concurrent administration of 2.0 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
|---|---|---|---|---|---|---|---|
|
Response to Treatment by Dose
Complete Response (CR)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
4 participants
|
0 participants
|
—
|
|
Response to Treatment by Dose
Complete response with incomplete recovery (CRi)
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
5 participants
|
0 participants
|
—
|
|
Response to Treatment by Dose
Partial Response (PR)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
—
|
|
Response to Treatment by Dose
Overall Response (CR+CRi+PR)
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
10 participants
|
1 participants
|
—
|
|
Response to Treatment by Dose
Complete Response (CR and CRi)
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
9 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Final evaluation - between Day 20 and Day 44Population: Data were not collected
Change in leukemic cell apoptosis in peripheral blood and bone marrow
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Blood samples for the determination of BL-8040 were collected before dosing and at 0.25, 0.5, 1, 2, 4, 8, and 24 hours after BL-8040 administration on Day 1.Population: PK Population
Pharmacokinetics (PK) of BL-8040 after daily subcutaneous (SC) dosing for 2 days alone, followed by 5 days of combined administration of BL-8040 + Ara-C by dose level. Standard Deviation is reported for N ≥ 3 t1/2 (h): The time required for plasma concentration of a drug to decrease by 50%
Outcome measures
| Measure |
BL-8040 + Ara-C
n=1 Participants
Eligible subjects received subcutaneous (SC) injections of BL-8040 ("monotherapy period") over two days (one injection per day) followed by concurrent administration of BL-8040 with standard salvage chemotherapy ("combined period") over 5 days. During the "combined period," BL-8040 was be administered 4 hours prior to chemotherapy. The chemotherapy consisted of cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age), administered intravenously (IV) over 3 hours, for 5 days without escalation.
Ara-C: IV
BL-8040: SC
|
Period 1: BL-8040 0.5 mg/kg + Ara-C
n=3 Participants
0.5 mg/kg BL-8040 administration over two days followed by concurrent administration of 0.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 2: BL-8040 0.75 mg/kg + Ara-C
n=5 Participants
0.75 mg/kg BL-8040 administration over two days followed by concurrent administration of 0.75 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days
|
Period 3: BL-8040 1.0 mg/kg + Ara-C
n=4 Participants
1.0 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.0 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 4: BL-8040 1.25 mg/kg + Ara-C
n=18 Participants
1.25 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.25 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 5 & Expansion: BL-8040 1.5 mg/kg + Ara-C
n=3 Participants
1.5 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 6: BL-8040 2.0 mg/kg + Ara-C
2.0 mg/kg BL-8040 administration over two days followed by concurrent administration of 2.0 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
|---|---|---|---|---|---|---|---|
|
Assessment of the Pharmacokinetic Profile of BL-8040 - t1/2 (h)
|
1.23 hours
|
1.50 hours
Standard Deviation 0.484
|
1.40 hours
Standard Deviation 0.336
|
2.06 hours
Standard Deviation 1.92
|
2.11 hours
Standard Deviation 1.57
|
2.67 hours
Standard Deviation 1.27
|
—
|
SECONDARY outcome
Timeframe: Blood samples for the determination of BL-8040 were collected before dosing and at 0.25, 0.5, 1, 2, 4, 8, and 24 hours after BL-8040 administration on Day 1.Population: PK Population
Pharmacokinetics (PK) of BL-8040 after daily subcutaneous (SC) dosing for 2 days alone, followed by 5 days of combined administration of BL-8040 + Ara-C by dose level. Standard Deviation is reported for N ≥ 3 tmax (h): The time to peak concentration
Outcome measures
| Measure |
BL-8040 + Ara-C
n=3 Participants
Eligible subjects received subcutaneous (SC) injections of BL-8040 ("monotherapy period") over two days (one injection per day) followed by concurrent administration of BL-8040 with standard salvage chemotherapy ("combined period") over 5 days. During the "combined period," BL-8040 was be administered 4 hours prior to chemotherapy. The chemotherapy consisted of cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age), administered intravenously (IV) over 3 hours, for 5 days without escalation.
Ara-C: IV
BL-8040: SC
|
Period 1: BL-8040 0.5 mg/kg + Ara-C
n=3 Participants
0.5 mg/kg BL-8040 administration over two days followed by concurrent administration of 0.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 2: BL-8040 0.75 mg/kg + Ara-C
n=6 Participants
0.75 mg/kg BL-8040 administration over two days followed by concurrent administration of 0.75 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days
|
Period 3: BL-8040 1.0 mg/kg + Ara-C
n=4 Participants
1.0 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.0 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 4: BL-8040 1.25 mg/kg + Ara-C
n=19 Participants
1.25 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.25 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 5 & Expansion: BL-8040 1.5 mg/kg + Ara-C
n=3 Participants
1.5 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 6: BL-8040 2.0 mg/kg + Ara-C
2.0 mg/kg BL-8040 administration over two days followed by concurrent administration of 2.0 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
|---|---|---|---|---|---|---|---|
|
Assessment of the Pharmacokinetic Profile of BL-8040 - Tmax (h)
|
0.833 hours
Standard Deviation 0.289
|
0.417 hours
Standard Deviation 0.144
|
0.792 hours
Standard Deviation 0.332
|
0.875 hours
Standard Deviation 0.250
|
0.618 hours
Standard Deviation 0.281
|
1 hours
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: Blood samples for the determination of BL-8040 were collected before dosing and at 0.25, 0.5, 1, 2, 4, 8, and 24 hours after BL-8040 administration on Day 1.Population: PK Population
Pharmacokinetics (PK) of BL-8040 after daily subcutaneous (SC) dosing for 2 days alone, followed by 5 days of combined administration of BL-8040 + Ara-C by dose level. Standard Deviation is reported for N ≥ 3 Cmax is the highest concentration of a drug in the blood
Outcome measures
| Measure |
BL-8040 + Ara-C
n=3 Participants
Eligible subjects received subcutaneous (SC) injections of BL-8040 ("monotherapy period") over two days (one injection per day) followed by concurrent administration of BL-8040 with standard salvage chemotherapy ("combined period") over 5 days. During the "combined period," BL-8040 was be administered 4 hours prior to chemotherapy. The chemotherapy consisted of cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age), administered intravenously (IV) over 3 hours, for 5 days without escalation.
Ara-C: IV
BL-8040: SC
|
Period 1: BL-8040 0.5 mg/kg + Ara-C
n=3 Participants
0.5 mg/kg BL-8040 administration over two days followed by concurrent administration of 0.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 2: BL-8040 0.75 mg/kg + Ara-C
n=6 Participants
0.75 mg/kg BL-8040 administration over two days followed by concurrent administration of 0.75 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days
|
Period 3: BL-8040 1.0 mg/kg + Ara-C
n=4 Participants
1.0 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.0 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 4: BL-8040 1.25 mg/kg + Ara-C
n=19 Participants
1.25 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.25 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 5 & Expansion: BL-8040 1.5 mg/kg + Ara-C
n=3 Participants
1.5 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 6: BL-8040 2.0 mg/kg + Ara-C
2.0 mg/kg BL-8040 administration over two days followed by concurrent administration of 2.0 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
|---|---|---|---|---|---|---|---|
|
Assessment of the Pharmacokinetic Profile of BL-8040 - Cmax (ng/mL)
|
380 ng/mL
Standard Deviation 33.6
|
376 ng/mL
Standard Deviation 155
|
712 ng/mL
Standard Deviation 277
|
1670 ng/mL
Standard Deviation 522
|
1940 ng/mL
Standard Deviation 803
|
4020 ng/mL
Standard Deviation 1510
|
—
|
SECONDARY outcome
Timeframe: Blood samples for the determination of BL-8040 were collected before dosing and at 0.25, 0.5, 1, 2, 4, 8, and 24 hours after BL-8040 administration on Day 1.Population: PK Population
Pharmacokinetics (PK) of BL-8040 after daily subcutaneous (SC) dosing for 2 days alone, followed by 5 days of combined administration of BL-8040 + Ara-C by dose level. Standard Deviation is reported for N ≥ 3 AUC0-t is the Area Under the Curve (AUC), definite integral of the concentration of a drug in blood as a function of time.
Outcome measures
| Measure |
BL-8040 + Ara-C
n=3 Participants
Eligible subjects received subcutaneous (SC) injections of BL-8040 ("monotherapy period") over two days (one injection per day) followed by concurrent administration of BL-8040 with standard salvage chemotherapy ("combined period") over 5 days. During the "combined period," BL-8040 was be administered 4 hours prior to chemotherapy. The chemotherapy consisted of cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age), administered intravenously (IV) over 3 hours, for 5 days without escalation.
Ara-C: IV
BL-8040: SC
|
Period 1: BL-8040 0.5 mg/kg + Ara-C
n=3 Participants
0.5 mg/kg BL-8040 administration over two days followed by concurrent administration of 0.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 2: BL-8040 0.75 mg/kg + Ara-C
n=6 Participants
0.75 mg/kg BL-8040 administration over two days followed by concurrent administration of 0.75 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days
|
Period 3: BL-8040 1.0 mg/kg + Ara-C
n=4 Participants
1.0 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.0 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 4: BL-8040 1.25 mg/kg + Ara-C
n=19 Participants
1.25 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.25 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 5 & Expansion: BL-8040 1.5 mg/kg + Ara-C
n=3 Participants
1.5 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 6: BL-8040 2.0 mg/kg + Ara-C
2.0 mg/kg BL-8040 administration over two days followed by concurrent administration of 2.0 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
|---|---|---|---|---|---|---|---|
|
Assessment of the Pharmacokinetic Profile of BL-8040 - AUC0-t (h*ng/mL)
|
661 h*ng/mL
Standard Deviation 55.3
|
792 h*ng/mL
Standard Deviation 447
|
1390 h*ng/mL
Standard Deviation 541
|
3020 h*ng/mL
Standard Deviation 1340
|
3650 h*ng/mL
Standard Deviation 1640
|
8340 h*ng/mL
Standard Deviation 2290
|
—
|
SECONDARY outcome
Timeframe: Blood samples for the determination of BL-8040 were collected before dosing and at 0.25, 0.5, 1, 2, 4, 8, and 24 hours after BL-8040 administration on Day 1.Population: PK Population
Pharmacokinetics (PK) of BL-8040 after daily subcutaneous (SC) dosing for 2 days alone, followed by 5 days of combined administration of BL-8040 + Ara-C by dose level. Standard Deviation is reported for N ≥ 3 AUC0-24 is the Area Under the Curve (AUC), definite integral of the concentration of a drug in blood from time zero to 24 hours post dose.
Outcome measures
| Measure |
BL-8040 + Ara-C
n=1 Participants
Eligible subjects received subcutaneous (SC) injections of BL-8040 ("monotherapy period") over two days (one injection per day) followed by concurrent administration of BL-8040 with standard salvage chemotherapy ("combined period") over 5 days. During the "combined period," BL-8040 was be administered 4 hours prior to chemotherapy. The chemotherapy consisted of cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age), administered intravenously (IV) over 3 hours, for 5 days without escalation.
Ara-C: IV
BL-8040: SC
|
Period 1: BL-8040 0.5 mg/kg + Ara-C
n=3 Participants
0.5 mg/kg BL-8040 administration over two days followed by concurrent administration of 0.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 2: BL-8040 0.75 mg/kg + Ara-C
n=5 Participants
0.75 mg/kg BL-8040 administration over two days followed by concurrent administration of 0.75 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days
|
Period 3: BL-8040 1.0 mg/kg + Ara-C
n=4 Participants
1.0 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.0 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 4: BL-8040 1.25 mg/kg + Ara-C
n=18 Participants
1.25 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.25 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 5 & Expansion: BL-8040 1.5 mg/kg + Ara-C
n=3 Participants
1.5 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
Period 6: BL-8040 2.0 mg/kg + Ara-C
2.0 mg/kg BL-8040 administration over two days followed by concurrent administration of 2.0 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days.
|
|---|---|---|---|---|---|---|---|
|
Assessment of the Pharmacokinetic Profile of BL-8040 - AUC0-24 (h*ng/mL)
|
671 h*ng/mL
|
809 h*ng/mL
Standard Deviation 439
|
1550 h*ng/mL
Standard Deviation 484
|
3060 h*ng/mL
Standard Deviation 1340
|
3840 h*ng/mL
Standard Deviation 1520
|
8370 h*ng/mL
Standard Deviation 2260
|
—
|
Adverse Events
BL-8040 + Ara-C - All Patients
Serious events: 21 serious events
Other events: 41 other events
Deaths: 2 deaths
Period 1: BL-8040 0.5 mg/kg + Ara-C
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Period 2: BL-8040 0.75 mg/kg + Ara-C
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Period 3: BL-8040 1.0 mg/kg + Ara-C
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Period 4: BL-8040 1.25 mg/kg + Ara-C
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Period 5 & Expansion: BL-8040 1.5 mg/kg + Ara-C
Serious events: 10 serious events
Other events: 22 other events
Deaths: 0 deaths
Open Label 2.0 mg/kg Period 6: BL-8040 2.0mg/kg + Ara-C
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BL-8040 + Ara-C - All Patients
n=42 participants at risk
BL-8040 administration over two days followed by concurrent administration of BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days
|
Period 1: BL-8040 0.5 mg/kg + Ara-C
n=3 participants at risk
0.5 mg/kg BL-8040 administration over two days followed by concurrent administration of 0.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days
|
Period 2: BL-8040 0.75 mg/kg + Ara-C
n=3 participants at risk
0.75 mg/kg BL-8040 administration over two days followed by concurrent administration of 0.75 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days
|
Period 3: BL-8040 1.0 mg/kg + Ara-C
n=6 participants at risk
1.0 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.0 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days
|
Period 4: BL-8040 1.25 mg/kg + Ara-C
n=4 participants at risk
1.25 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.25 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days
|
Period 5 & Expansion: BL-8040 1.5 mg/kg + Ara-C
n=23 participants at risk
1.5 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days
|
Open Label 2.0 mg/kg Period 6: BL-8040 2.0mg/kg + Ara-C
n=3 participants at risk
2.0 mg/kg BL-8040 administration over two days followed by concurrent administration of 2.0 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
26.2%
11/42 • Number of events 11 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
26.1%
6/23 • Number of events 6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
General disorders
PYREXIA
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
4.3%
1/23 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
General disorders
CHEST PAIN
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Immune system disorders
HYPERSENSITIVITY
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
4.3%
1/23 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Infections and infestations
ESCHERICHIA BACTERAEMIA
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Injury, poisoning and procedural complications
FALL
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
4.3%
1/23 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Nervous system disorders
ATAXIA
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Nervous system disorders
PRESYNCOPE
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Skin and subcutaneous tissue disorders
ACUTE FEBRILE NEUTROPHILIC DERMATOSIS
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
4.3%
1/23 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Vascular disorders
HYPOTENSION
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
4.3%
1/23 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Infections and infestations
Pneumonia
|
11.9%
5/42 • Number of events 6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
2/6 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
4.3%
1/23 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Infections and infestations
Alpha haemolytic streptococcal infection
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
4.3%
1/23 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Infections and infestations
Lung Infection
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
Other adverse events
| Measure |
BL-8040 + Ara-C - All Patients
n=42 participants at risk
BL-8040 administration over two days followed by concurrent administration of BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days
|
Period 1: BL-8040 0.5 mg/kg + Ara-C
n=3 participants at risk
0.5 mg/kg BL-8040 administration over two days followed by concurrent administration of 0.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days
|
Period 2: BL-8040 0.75 mg/kg + Ara-C
n=3 participants at risk
0.75 mg/kg BL-8040 administration over two days followed by concurrent administration of 0.75 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days
|
Period 3: BL-8040 1.0 mg/kg + Ara-C
n=6 participants at risk
1.0 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.0 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days
|
Period 4: BL-8040 1.25 mg/kg + Ara-C
n=4 participants at risk
1.25 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.25 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days
|
Period 5 & Expansion: BL-8040 1.5 mg/kg + Ara-C
n=23 participants at risk
1.5 mg/kg BL-8040 administration over two days followed by concurrent administration of 1.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days
|
Open Label 2.0 mg/kg Period 6: BL-8040 2.0mg/kg + Ara-C
n=3 participants at risk
2.0 mg/kg BL-8040 administration over two days followed by concurrent administration of 2.0 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) over 5 days
|
|---|---|---|---|---|---|---|---|
|
General disorders
Injection site bruising
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
General disorders
Injection site erythema
|
26.2%
11/42 • Number of events 12 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
66.7%
2/3 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
21.7%
5/23 • Number of events 5 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
General disorders
Injection site induration
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
General disorders
Injection site joint pain
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
General disorders
Injection site pain
|
59.5%
25/42 • Number of events 55 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
100.0%
3/3 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
66.7%
4/6 • Number of events 9 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
50.0%
2/4 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
56.5%
13/23 • Number of events 36 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
66.7%
2/3 • Number of events 4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
General disorders
INJECTION SITE REACTION
|
11.9%
5/42 • Number of events 5 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
13.0%
3/23 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
66.7%
2/3 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
21.4%
9/42 • Number of events 10 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
30.4%
7/23 • Number of events 8 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.9%
5/42 • Number of events 5 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
4.3%
1/23 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.5%
4/42 • Number of events 4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
8.7%
2/23 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
14/42 • Number of events 15 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
39.1%
9/23 • Number of events 10 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenic purpura
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Cardiac disorders
Palpitations
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
66.7%
2/3 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Cardiac disorders
Bradycardia
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
8.7%
2/23 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Cardiac disorders
Tachycardia
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
8.7%
2/23 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
7.1%
3/42 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
8.7%
2/23 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Cardiac disorders
Sinus bradycardia
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Ear and labyrinth disorders
Vertigo
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Endocrine disorders
Hypothyroidism
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Eye disorders
Lacrimation increased
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Eye disorders
Blepharitis
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Eye disorders
Eye pain
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Eye disorders
Vision blurred
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
8.7%
2/23 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Gastrointestinal disorders
Proctalgia
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
8.7%
2/23 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Gastrointestinal disorders
Diarrhoea
|
35.7%
15/42 • Number of events 15 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
66.7%
2/3 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
50.0%
2/4 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
30.4%
7/23 • Number of events 7 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
66.7%
2/3 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
4.3%
1/23 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Gastrointestinal disorders
Constipation
|
40.5%
17/42 • Number of events 18 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
66.7%
2/3 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
43.5%
10/23 • Number of events 10 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Gastrointestinal disorders
Gingival bleeding
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
8.7%
2/23 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.1%
3/42 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
8.7%
2/23 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Gastrointestinal disorders
Nausea
|
38.1%
16/42 • Number of events 20 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
66.7%
2/3 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
50.0%
3/6 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
30.4%
7/23 • Number of events 10 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
66.7%
2/3 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Gastrointestinal disorders
Vomiting
|
31.0%
13/42 • Number of events 15 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
66.7%
2/3 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
50.0%
2/4 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
39.1%
9/23 • Number of events 10 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Gastrointestinal disorders
Haematochezia
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
4.3%
1/23 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Gastrointestinal disorders
Leukoplakia oral
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Gastrointestinal disorders
Oral pain
|
7.1%
3/42 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
8.7%
2/23 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Gastrointestinal disorders
Stomatitis
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Gastrointestinal disorders
Lip Ulceration
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
General disorders
Asthenia
|
7.1%
3/42 • Number of events 4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
66.7%
2/3 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
4.3%
1/23 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
General disorders
Fatigue
|
26.2%
11/42 • Number of events 11 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
39.1%
9/23 • Number of events 9 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
General disorders
Pyrexia
|
21.4%
9/42 • Number of events 11 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
30.4%
7/23 • Number of events 9 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
General disorders
Chills
|
9.5%
4/42 • Number of events 4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
13.0%
3/23 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
General disorders
Injection site pruritus
|
23.8%
10/42 • Number of events 11 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
50.0%
2/4 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
26.1%
6/23 • Number of events 7 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
General disorders
Injection site rash
|
26.2%
11/42 • Number of events 11 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
66.7%
2/3 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
21.7%
5/23 • Number of events 5 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
66.7%
2/3 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
General disorders
Injection site swelling
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
General disorders
Injection site urticaria
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
4.3%
1/23 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
General disorders
Injection site warmth
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
General disorders
Mucosal inflammation
|
11.9%
5/42 • Number of events 5 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
17.4%
4/23 • Number of events 4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
General disorders
Generalised oedema
|
4.8%
2/42 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
4.3%
1/23 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
General disorders
Oedema
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
4.3%
1/23 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
General disorders
Oedema peripheral
|
14.3%
6/42 • Number of events 6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
13.0%
3/23 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
General disorders
Chest pain
|
11.9%
5/42 • Number of events 5 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
13.0%
3/23 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
General disorders
Pain
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
8.7%
2/23 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Immune system disorders
Hypersensitivity
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
4.3%
1/23 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Infections and infestations
Cellulitis
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Infections and infestations
Stomatococcal infection
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Infections and infestations
Oral candidiasis
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
8.7%
2/23 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Infections and infestations
Enterococcal infection
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
4.3%
1/23 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Infections and infestations
Catheter site infection
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Infections and infestations
Lung infection
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Infections and infestations
Pseudomonal bacteraemia
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Infections and infestations
Bacteraemia
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
4.3%
1/23 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Infections and infestations
Sepsis
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
8.7%
2/23 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Infections and infestations
Staphylococcal infection
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Infections and infestations
Alpha haemolytic streptococcal infection
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Infections and infestations
Urinary tract infection
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
4.3%
1/23 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Injury, poisoning and procedural complications
Tongue injury
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
7.1%
3/42 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
8.7%
2/23 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Investigations
Enterobacter test positive
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
6/42 • Number of events 6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
66.7%
2/3 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
8.7%
2/23 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
3/42 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Investigations
Blood phosphorus increased
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
66.7%
2/3 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Investigations
Weight decreased
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
8.7%
2/23 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
21.4%
9/42 • Number of events 9 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
30.4%
7/23 • Number of events 7 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.1%
3/42 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
8.7%
2/23 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Metabolism and nutrition disorders
Hyperglicaemia
|
7.1%
3/42 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
4.3%
1/23 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.1%
3/42 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
8.7%
2/23 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
7/42 • Number of events 7 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
21.7%
5/23 • Number of events 5 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
8.7%
2/23 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Metabolism and nutrition disorders
Fluid retention
|
9.5%
4/42 • Number of events 4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
13.0%
3/23 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
4.3%
1/23 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.9%
5/42 • Number of events 5 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
17.4%
4/23 • Number of events 4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
3/42 • Number of events 4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
4.3%
1/23 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Nervous system disorders
Dizziness
|
23.8%
10/42 • Number of events 11 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
34.8%
8/23 • Number of events 9 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Nervous system disorders
Headache
|
35.7%
15/42 • Number of events 17 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
66.7%
4/6 • Number of events 4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
30.4%
7/23 • Number of events 9 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
66.7%
2/3 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Nervous system disorders
Paraesthesia
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Nervous system disorders
Syncope
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
8.7%
2/23 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Psychiatric disorders
Insomnia
|
16.7%
7/42 • Number of events 7 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
13.0%
3/23 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Psychiatric disorders
Anxiety
|
11.9%
5/42 • Number of events 5 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
17.4%
4/23 • Number of events 4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Renal and urinary disorders
Haematuria
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.5%
4/42 • Number of events 4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
8.7%
2/23 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
6/42 • Number of events 6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
13.0%
3/23 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.9%
5/42 • Number of events 5 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
17.4%
4/23 • Number of events 4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.9%
5/42 • Number of events 5 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
13.0%
3/23 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.1%
3/42 • Number of events 4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
4.3%
1/23 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
4.3%
1/23 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
7/42 • Number of events 10 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
13.0%
3/23 • Number of events 6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
6/42 • Number of events 7 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
8.7%
2/23 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
31.0%
13/42 • Number of events 13 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
66.7%
2/3 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
30.4%
7/23 • Number of events 7 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
66.7%
2/3 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Generalised erythema
|
2.4%
1/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
9.5%
4/42 • Number of events 4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
13.0%
3/23 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
9.5%
4/42 • Number of events 4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
13.0%
3/23 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.8%
2/42 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
8.7%
2/23 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Vascular disorders
Hypotension
|
16.7%
7/42 • Number of events 8 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
21.7%
5/23 • Number of events 6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Vascular disorders
Hypertension
|
11.9%
5/42 • Number of events 6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
8.7%
2/23 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 2 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Vascular disorders
Thrombophlebitis superficial
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
25.0%
1/4 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Vascular disorders
Deep vein thrombosis
|
7.1%
3/42 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
13.0%
3/23 • Number of events 3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Vascular disorders
Flushing
|
16.7%
7/42 • Number of events 10 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
26.1%
6/23 • Number of events 9 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Vascular disorders
Hypovolaemic shock
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
Injury, poisoning and procedural complications
Laceration
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
|
General disorders
Catheter site haematoma
|
2.4%
1/42 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/6 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/4 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/23 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
0.00%
0/3 • Adverse Events (AEs) were assessed at all study visits throughout the study from completion of Informed Consent Form (ICF) until End of Study for each patient, which is approximately 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER