Trial Outcomes & Findings for Efficacy and Safety of Decitabine as Epigenetic Priming With Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects (NCT NCT01177540)
NCT ID: NCT01177540
Last Updated: 2022-06-28
Results Overview
Disease response measurements were based on bone marrow evaluations (biopsies, aspirates, or both) performed by local pathology laboratories and assessed by study investigators. A designation of CR required that the participant achieve a morphologic leukemia-free state and have an absolute neutrophil count (ANC) greater than 1000 per microliter (/mcL) and a platelet count greater than 100,000/mcL.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Day 50
Results posted on
2022-06-28
Participant Flow
Participants took part in the study at 11 investigative sites in Australia, Canada and the United States from 3 March 2011 to 19 July 2013.
A total of 98 participants were screened, of which 25 were enrolled and treated in the study.
Participant milestones
| Measure |
Treatment A: Decitabine + Induction Chemotherapy
Participants received decitabine 20 milligram per square meter (mg/m\^2) infusion, intravenously, daily from Days 1 to 5, followed by induction chemotherapy of daunorubicin, cytarabine, etoposide for 10 days.
|
Treatment B: Induction Chemotherapy Only
Participants received induction chemotherapy of daunorubicin, cytarabine, etoposide only for 10 days.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
14
|
|
Overall Study
COMPLETED
|
10
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Treatment A: Decitabine + Induction Chemotherapy
Participants received decitabine 20 milligram per square meter (mg/m\^2) infusion, intravenously, daily from Days 1 to 5, followed by induction chemotherapy of daunorubicin, cytarabine, etoposide for 10 days.
|
Treatment B: Induction Chemotherapy Only
Participants received induction chemotherapy of daunorubicin, cytarabine, etoposide only for 10 days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of Decitabine as Epigenetic Priming With Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects
Baseline characteristics by cohort
| Measure |
Treatment A: Decitabine + Induction Chemotherapy
n=11 Participants
Participants received decitabine 20 mg/m\^2 infusion, intravenously, daily from Days 1 to 5, followed by induction chemotherapy of daunorubicin, cytarabine, etoposide for 10 days.
|
Treatment B: Induction Chemotherapy Only
n=14 Participants
Participants received induction chemotherapy of daunorubicin, cytarabine, etoposide only for 10 days.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
1 to less than (<) 2 years
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Age, Customized
2 to 11 years
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Age, Customized
12 to 16 years
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 50Population: The full analysis set included all participants who received at least one dose of study treatment and who had at least one postdose efficacy measurement for response.
Disease response measurements were based on bone marrow evaluations (biopsies, aspirates, or both) performed by local pathology laboratories and assessed by study investigators. A designation of CR required that the participant achieve a morphologic leukemia-free state and have an absolute neutrophil count (ANC) greater than 1000 per microliter (/mcL) and a platelet count greater than 100,000/mcL.
Outcome measures
| Measure |
Treatment A: Decitabine + Induction Chemotherapy
n=11 Participants
Participants received decitabine 20 mg/m\^2 infusion, intravenously, daily from Days 1 to 5, followed by induction chemotherapy of daunorubicin, cytarabine, etoposide for 10 days.
|
Treatment B: Induction Chemotherapy Only
n=14 Participants
Participants received induction chemotherapy of daunorubicin, cytarabine, etoposide only for 10 days.
|
|---|---|---|
|
Percentage of Participants With Morphologic Complete Remission (CR)
|
27.3 percentage of participants
Interval 6.0 to 61.0
|
50.0 percentage of participants
Interval 23.0 to 77.0
|
SECONDARY outcome
Timeframe: Baseline up to completion of induction therapy (Day 15)Population: The full analysis set included all participants who received at least one dose of study treatment and who had at least one postdose efficacy measurement for response.
Bone marrow samples were obtained at baseline and completion of induction therapy. DNA was extracted, and global DNA methylation was evaluated using the Infinium® Human Methylation450® BeadChip Array according to the manufacturer's protocol (Illumina, San Diego, California). Paired differential methylation analysis of end-induction marrows to participant matched screening marrows was performed to identify differentially methylated cytosines followed by guanine residue (CpG) loci (DML). A paired Wilcoxon rank test was conducted to compare end-induction marrows with diagnostic marrows within each arm to identify loci considered statistically significant and differentially methylated. Three different behaviors were defined: 'hypermethylation' (increased intensity in the tumor), 'hypomethylation' (decreased intensity in the tumor) and 'no change' (no substantial differences of intensity).
Outcome measures
| Measure |
Treatment A: Decitabine + Induction Chemotherapy
n=6990 Loci
Participants received decitabine 20 mg/m\^2 infusion, intravenously, daily from Days 1 to 5, followed by induction chemotherapy of daunorubicin, cytarabine, etoposide for 10 days.
|
Treatment B: Induction Chemotherapy Only
n=1090 Loci
Participants received induction chemotherapy of daunorubicin, cytarabine, etoposide only for 10 days.
|
|---|---|---|
|
DNA Methylation
Hypomethylated DML
|
4134 Loci
|
785 Loci
|
|
DNA Methylation
Hypermethylated DML
|
2856 Loci
|
305 Loci
|
SECONDARY outcome
Timeframe: Baseline to recurrence of Leukemia or Death (up to 2 years 5 months)Population: The per protocol set included all participants who sufficiently complied with protocol. Here "overall number of participants analyzed" are participants who achieved morphologic CR and were available for this outcome measure assessment at given time period.
LFS was defined as time from CR until the recurrence of leukemia (greater than or equal to \[\>=\] 5% bone marrow blasts, reappearance of peripheral blasts or the appearance of new dysplastic changes, or death, whichever occurred first). For participants who did not achieve a CR, LFS is set to zero days. For participants with CR who do not have leukemic recurrence or death, data for LFS was censored on the date of the last follow-up bone marrow or hematology examination, whichever is later. LFS was analyzed using Kaplan-Meier method.
Outcome measures
| Measure |
Treatment A: Decitabine + Induction Chemotherapy
n=3 Participants
Participants received decitabine 20 mg/m\^2 infusion, intravenously, daily from Days 1 to 5, followed by induction chemotherapy of daunorubicin, cytarabine, etoposide for 10 days.
|
Treatment B: Induction Chemotherapy Only
n=7 Participants
Participants received induction chemotherapy of daunorubicin, cytarabine, etoposide only for 10 days.
|
|---|---|---|
|
Leukemia-free Survival (LFS)
|
NA days
There were insufficient data as of the clinical cut date to calculate median and full range from the Kaplan-Meier analysis of LFS.
|
NA days
There were insufficient data as of the clinical cut date to calculate median and full range from the Kaplan-Meier analysis of LFS.
|
SECONDARY outcome
Timeframe: Baseline to Date of Death (up to 2 years 5 months)Population: The per protocol set included all participants who sufficiently complied with protocol.
OS was defined as the time from the date of the first dose of study treatment to the date of death from any cause. OS was analyzed using Kaplan-Meier method.
Outcome measures
| Measure |
Treatment A: Decitabine + Induction Chemotherapy
n=11 Participants
Participants received decitabine 20 mg/m\^2 infusion, intravenously, daily from Days 1 to 5, followed by induction chemotherapy of daunorubicin, cytarabine, etoposide for 10 days.
|
Treatment B: Induction Chemotherapy Only
n=14 Participants
Participants received induction chemotherapy of daunorubicin, cytarabine, etoposide only for 10 days.
|
|---|---|---|
|
Overall Survival (OS)
|
NA months
Interval 6.7 to 24.5
The median OS was not yet reached for either Treatment A or Treatment B arm at final data cutoff date.
|
NA months
Interval 6.2 to 26.2
The median OS was not yet reached for either Treatment A or Treatment B arm at final data cutoff date.
|
SECONDARY outcome
Timeframe: Baseline and Day 50Population: The full analysis set included all participants who received at least one dose of study treatment and who had at least one postdose efficacy measurement for response. Here "overall number of participants analyzed" are participants who were available for this outcome measure assessment at given time points.
After induction chemotherapy, based on bone marrow biopsies. No formal statistical analyses of MRD were performed for this study.
Outcome measures
| Measure |
Treatment A: Decitabine + Induction Chemotherapy
n=8 Participants
Participants received decitabine 20 mg/m\^2 infusion, intravenously, daily from Days 1 to 5, followed by induction chemotherapy of daunorubicin, cytarabine, etoposide for 10 days.
|
Treatment B: Induction Chemotherapy Only
n=9 Participants
Participants received induction chemotherapy of daunorubicin, cytarabine, etoposide only for 10 days.
|
|---|---|---|
|
Percentage of Participants With Minimal Residual Disease (MRD) at Baseline and Day 50
At Baseline
|
75 percentage of participants
|
NA percentage of participants
Data was not collected and analyzed as the samples were not processed for all 9 participants due to lack of viability, degradation, or was outside established time frame for processing.
|
|
Percentage of Participants With Minimal Residual Disease (MRD) at Baseline and Day 50
At Day 50
|
25 percentage of participants
|
11 percentage of participants
|
SECONDARY outcome
Timeframe: Randomization to Day 50Population: The full analysis set included all participants who received at least one dose of study treatment and who had at least one postdose efficacy measurement for response. Here "overall number of participants analyzed" are participants who achieved morphologic CR and were available for this outcome measure assessment at given time period.
Disease response measurements were based on bone marrow evaluations (biopsies, aspirates, or both) performed by local pathology laboratories an assessed by study investigators. CR: requires that the participant achieved a morphologic leukemia-free state and had an ANC \>1000/mcL and platelets \>100,000/mcL. Hemoglobin concentration or hematocrit had no bearing on remission status, although the participant had to be independent of transfusions. Kaplan-Meier curves were used to describe time to CR.
Outcome measures
| Measure |
Treatment A: Decitabine + Induction Chemotherapy
n=3 Participants
Participants received decitabine 20 mg/m\^2 infusion, intravenously, daily from Days 1 to 5, followed by induction chemotherapy of daunorubicin, cytarabine, etoposide for 10 days.
|
Treatment B: Induction Chemotherapy Only
n=7 Participants
Participants received induction chemotherapy of daunorubicin, cytarabine, etoposide only for 10 days.
|
|---|---|---|
|
Time to CR
|
43.0 days
Interval 35.0 to
Upper limit of 95% confidence interval (CI) could not be calculated since maximum number of participants had delayed recovery in ANC counts.
|
37.0 days
Interval 32.0 to 40.0
|
SECONDARY outcome
Timeframe: Baseline up to Day 50Population: The full analysis set included all participants who received at least one dose of study treatment and who had at least one postdose efficacy measurement for response. Here "overall number of participants analyzed" are participants who were available for this outcome measure assessment at given time period.
Blood sampling was used to determine recovery, and is defined as less than or equal to 1000 per cubic millimeter (/mm\^3) for absolute neutrophil count (ANC). Summarized using Kaplan-Meier product limit estimators.
Outcome measures
| Measure |
Treatment A: Decitabine + Induction Chemotherapy
n=9 Participants
Participants received decitabine 20 mg/m\^2 infusion, intravenously, daily from Days 1 to 5, followed by induction chemotherapy of daunorubicin, cytarabine, etoposide for 10 days.
|
Treatment B: Induction Chemotherapy Only
n=10 Participants
Participants received induction chemotherapy of daunorubicin, cytarabine, etoposide only for 10 days.
|
|---|---|---|
|
Time to Neutrophil Recovery
|
26.0 days
Interval 13.0 to 43.0
|
18.0 days
Interval 15.0 to 25.0
|
SECONDARY outcome
Timeframe: Baseline up to Day 38Population: The full analysis set included all participants who received at least one dose of study treatment and who had at least one postdose efficacy measurement for response All participants in FAS had platelet recovery.
Blood sampling was used to determine recovery and is defined as less than or equal to 100,000/mm\^3 for platelet count. Summarized using Kaplan-Meier product limit estimators.
Outcome measures
| Measure |
Treatment A: Decitabine + Induction Chemotherapy
n=11 Participants
Participants received decitabine 20 mg/m\^2 infusion, intravenously, daily from Days 1 to 5, followed by induction chemotherapy of daunorubicin, cytarabine, etoposide for 10 days.
|
Treatment B: Induction Chemotherapy Only
n=14 Participants
Participants received induction chemotherapy of daunorubicin, cytarabine, etoposide only for 10 days.
|
|---|---|---|
|
Time to Platelet Recovery
|
22.0 days
Interval 6.0 to 26.0
|
14.5 days
Interval 8.0 to 18.0
|
Adverse Events
Treatment A: Decitabine + Induction Chemotherapy
Serious events: 2 serious events
Other events: 8 other events
Deaths: 3 deaths
Treatment B: Induction Chemotherapy Only
Serious events: 1 serious events
Other events: 9 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Treatment A: Decitabine + Induction Chemotherapy
n=11 participants at risk
Participants received decitabine 20 mg/m\^2 infusion, intravenously, daily from Days 1 to 5, followed by induction chemotherapy of daunorubicin, cytarabine, etoposide for 10 days.
|
Treatment B: Induction Chemotherapy Only
n=14 participants at risk
Participants received induction chemotherapy of daunorubicin, cytarabine, etoposide only for 10 days.
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Injury, poisoning and procedural complications
Large intestine perforation
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Infections and infestations
Sepsis
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
Other adverse events
| Measure |
Treatment A: Decitabine + Induction Chemotherapy
n=11 participants at risk
Participants received decitabine 20 mg/m\^2 infusion, intravenously, daily from Days 1 to 5, followed by induction chemotherapy of daunorubicin, cytarabine, etoposide for 10 days.
|
Treatment B: Induction Chemotherapy Only
n=14 participants at risk
Participants received induction chemotherapy of daunorubicin, cytarabine, etoposide only for 10 days.
|
|---|---|---|
|
Vascular disorders
Hypotension
|
45.5%
5/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Vascular disorders
Orthostatic hypotension
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Vascular disorders
Pallor
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Vascular disorders
Phlebitis
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
54.5%
6/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
28.6%
4/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Blood and lymphatic system disorders
Coagulopathy
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
28.6%
4/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
27.3%
3/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
36.4%
4/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
14.3%
2/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Cardiac disorders
Bradycardia
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
14.3%
2/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Cardiac disorders
Sinus arrhythmia
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Cardiac disorders
Sinus bradycardia
|
18.2%
2/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Cardiac disorders
Sinus tachycardia
|
18.2%
2/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Cardiac disorders
Tachycardia
|
27.3%
3/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
21.4%
3/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Ear and labyrinth disorders
Tinnitus
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Eye disorders
Dry eye
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Eye disorders
Vision blurred
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Eye disorders
Visual impairment
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
27.3%
3/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
42.9%
6/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Abdominal tenderness
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Anorectal discomfort
|
18.2%
2/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Ascites
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Caecitis
|
18.2%
2/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Colitis
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Constipation
|
45.5%
5/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
14.3%
2/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
54.5%
6/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
28.6%
4/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Faeces discoloured
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Flatulence
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Gastric fistula
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Gingival bleeding
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Gingivitis
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Lip disorder
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Lip dry
|
18.2%
2/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Lip pain
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
18.2%
2/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Mouth ulceration
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Nausea
|
36.4%
4/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
35.7%
5/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Oral pain
|
36.4%
4/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Proctalgia
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Proctitis
|
18.2%
2/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Stomatitis
|
18.2%
2/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
14.3%
2/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Swollen tongue
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Toothache
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Gastrointestinal disorders
Vomiting
|
45.5%
5/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
21.4%
3/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Asthenia
|
18.2%
2/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Catheter site discharge
|
18.2%
2/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Catheter site erosion
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Catheter site erythema
|
45.5%
5/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
14.3%
2/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Catheter site haematoma
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Catheter site haemorrhage
|
18.2%
2/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Catheter site oedema
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Catheter site pain
|
27.3%
3/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
21.4%
3/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Catheter site pruritus
|
27.3%
3/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Catheter site related reaction
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Chest discomfort
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Chest pain
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Chills
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Fatigue
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Generalised oedema
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Hypothermia
|
18.2%
2/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Localised oedema
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Medical device complication
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Mucosal inflammation
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Nodule
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Oedema peripheral
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Pain
|
18.2%
2/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Puncture site pain
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Pyrexia
|
27.3%
3/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
14.3%
2/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Swelling
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
General disorders
Thrombosis in device
|
18.2%
2/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Hepatobiliary disorders
Cholangitis
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Hepatobiliary disorders
Hepatomegaly
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Immune system disorders
Drug hypersensitivity
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Immune system disorders
Graft versus host disease
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Immune system disorders
Hypersensitivity
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Infections and infestations
Lower respiratory tract infection
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Infections and infestations
Lung infection
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Infections and infestations
Pneumonia
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Injury, poisoning and procedural complications
Contusion
|
18.2%
2/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Injury, poisoning and procedural complications
Laceration
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Injury, poisoning and procedural complications
Tongue injury
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Injury, poisoning and procedural complications
Wound
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Investigations
Blood creatinine increased
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Investigations
Breath sounds abnormal
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Investigations
Cardiac murmur
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Investigations
Granulocyte count decreased
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Investigations
Heart rate irregular
|
18.2%
2/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Investigations
Lymphocyte count decreased
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
21.4%
3/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Investigations
Platelet count decreased
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
21.4%
3/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Investigations
Weight decreased
|
27.3%
3/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
28.6%
4/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Investigations
Weight increased
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Investigations
White blood cell count decreased
|
54.5%
6/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
35.7%
5/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
54.5%
6/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
21.4%
3/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
27.3%
3/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
18.2%
2/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.2%
2/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
14.3%
2/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.2%
2/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Musculoskeletal and connective tissue disorders
Soft tissue mass
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Nervous system disorders
Cognitive disorder
|
18.2%
2/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Nervous system disorders
Dizziness
|
18.2%
2/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Nervous system disorders
Dizziness postural
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Nervous system disorders
Headache
|
27.3%
3/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
28.6%
4/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Nervous system disorders
Lethargy
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Nervous system disorders
Migraine
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Nervous system disorders
Presyncope
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Nervous system disorders
Somnolence
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Psychiatric disorders
Agitation
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
14.3%
2/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Psychiatric disorders
Mood altered
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Psychiatric disorders
Restlessness
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Psychiatric disorders
Social avoidant behaviour
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Renal and urinary disorders
Bladder disorder
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Renal and urinary disorders
Cystitis noninfective
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Renal and urinary disorders
Dysuria
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Renal and urinary disorders
Urinary incontinence
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Reproductive system and breast disorders
Menstrual disorder
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Reproductive system and breast disorders
Menstruation irregular
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Reproductive system and breast disorders
Penis disorder
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Reproductive system and breast disorders
Vaginal discharge
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
18.2%
2/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Bradypnoea
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
2/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.2%
2/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
21.4%
3/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
14.3%
2/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
27.3%
3/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
36.4%
4/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
21.4%
3/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
18.2%
2/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Skin and subcutaneous tissue disorders
Papule
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
27.3%
3/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
27.3%
3/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
21.4%
3/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.3%
3/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
14.3%
2/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
14.3%
2/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
7.1%
1/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
14.3%
2/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Vascular disorders
Haematoma
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Vascular disorders
Hot flush
|
9.1%
1/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
|
Vascular disorders
Hypertension
|
27.3%
3/11 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
0.00%
0/14 • For each participant, from the time the participant signed the informed consent form until the AE resolved, or for 30 days after the participant's last study visit, whichever came first (approximately up to 2 years and 5 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place