Trial Outcomes & Findings for Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso (NCT NCT03950739)
NCT ID: NCT03950739
Last Updated: 2024-11-01
Results Overview
6MWD was evaluated at study entry and after 3 weeks of treatment with TreT.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
51 participants
Primary outcome timeframe
From Baseline to 3 weeks of treatment with TreT
Results posted on
2024-11-01
Participant Flow
Participant milestones
| Measure |
Tyvaso to TreT
Each subject received a corresponding dose of TreT for 3 weeks during the Treatment Phase based on the subject's current stable Tyvaso dose.
Treprostinil Inhalation Powder: Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)
|
|---|---|
|
Treatment Phase
STARTED
|
51
|
|
Treatment Phase
COMPLETED
|
49
|
|
Treatment Phase
NOT COMPLETED
|
2
|
|
Optional Extension Phase
STARTED
|
49
|
|
Optional Extension Phase
COMPLETED
|
31
|
|
Optional Extension Phase
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Tyvaso to TreT
Each subject received a corresponding dose of TreT for 3 weeks during the Treatment Phase based on the subject's current stable Tyvaso dose.
Treprostinil Inhalation Powder: Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)
|
|---|---|
|
Treatment Phase
Adverse Event
|
2
|
|
Optional Extension Phase
Death
|
1
|
|
Optional Extension Phase
Progressive Disease
|
5
|
|
Optional Extension Phase
Adverse Event
|
7
|
|
Optional Extension Phase
Lost to Follow-up
|
2
|
|
Optional Extension Phase
Site Closure
|
2
|
|
Optional Extension Phase
Pregnancy
|
1
|
Baseline Characteristics
Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso
Baseline characteristics by cohort
| Measure |
Tyvaso to TreT
n=51 Participants
Each subject received a corresponding dose of TreT for 3 weeks during the Treatment Phase based on the subject's current stable Tyvaso dose.
Treprostinil Inhalation Powder: Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)
|
|---|---|
|
Age, Continuous
|
57.0 years
n=5 Participants
|
|
Age, Customized
<65 years
|
38 Participants
n=5 Participants
|
|
Age, Customized
≥65 years
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
|
Time Since PAH Diagnosis
|
7.820 years
n=5 Participants
|
|
Current PAH Diagnosis
Idiopathic/Familial
|
29 Participants
n=5 Participants
|
|
Current PAH Diagnosis
Associated with Unrepaired or Repaired Congenital Systemic-to-Pulmonary Shunts
|
4 Participants
n=5 Participants
|
|
Current PAH Diagnosis
Associated with Collagen Vascular Disease
|
14 Participants
n=5 Participants
|
|
Current PAH Diagnosis
Associated with HIV
|
1 Participants
n=5 Participants
|
|
Current PAH Diagnosis
Associated with Appetite Suppressant/Other Drug or Toxin Use
|
3 Participants
n=5 Participants
|
|
WHO Functional Class at Screening
I
|
6 Participants
n=5 Participants
|
|
WHO Functional Class at Screening
II
|
31 Participants
n=5 Participants
|
|
WHO Functional Class at Screening
III
|
14 Participants
n=5 Participants
|
|
Background PAH Medications
Endothelin receptor antagonist
|
43 participants
n=5 Participants
|
|
Background PAH Medications
Phosphodiesterase type 5 inhibitor
|
41 participants
n=5 Participants
|
|
Background PAH Medications
Soluble guanylate cyclase
|
7 participants
n=5 Participants
|
|
Background PAH Medications
No background PAH medication
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline to 3 weeks of treatment with TreTPopulation: Safety Population with 6MWD measurements at Week 3
6MWD was evaluated at study entry and after 3 weeks of treatment with TreT.
Outcome measures
| Measure |
Tyvaso to TreT
n=46 Participants
Each subject received a corresponding dose of TreT for 3 weeks during the Treatment Phase based on the subject's current stable Tyvaso dose.
Treprostinil Inhalation Powder: Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)
|
|---|---|
|
Change in 6-Minute Walk Distance (6MWD) From Baseline to Week 3
|
11.5 meters
Standard Deviation 32.9
|
PRIMARY outcome
Timeframe: After 3 weeks of treatment with TreT (after switching from the Tyvaso Inhalation System)Population: Safety Population with PQ-ITD responses at Week 3
Subject satisfaction with and preference for the inhaled treprostinil device was evaluated with the Preference Questionnaire for Inhaled Treprostinil Devices (PQ-ITD). The PQ-ITD is a questionnaire given to evaluate subject satisfaction with and preference for inhaled treprostinil devices. The questionnaire provides 12 different statements around inhaled device satisfaction and allows for 5 response options: strongly disagree, disagree, neutral, agree, and strongly agree.
Outcome measures
| Measure |
Tyvaso to TreT
n=46 Participants
Each subject received a corresponding dose of TreT for 3 weeks during the Treatment Phase based on the subject's current stable Tyvaso dose.
Treprostinil Inhalation Powder: Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)
|
|---|---|
|
Subject Satisfaction With and Preference for Inhaled Treprostinil Devices
Strongly Disagree
|
0 Participants
|
|
Subject Satisfaction With and Preference for Inhaled Treprostinil Devices
Disagree
|
0 Participants
|
|
Subject Satisfaction With and Preference for Inhaled Treprostinil Devices
Neutral
|
1 Participants
|
|
Subject Satisfaction With and Preference for Inhaled Treprostinil Devices
Strongly Agree
|
40 Participants
|
|
Subject Satisfaction With and Preference for Inhaled Treprostinil Devices
Agree
|
5 Participants
|
PRIMARY outcome
Timeframe: From Baseline to 3 weeks of treatment with TreTPopulation: Safety Population with PAH-SYMPACT scores at Week 3
Patient-reported PAH symptoms and impact were evaluated with the PAH Symptoms and Impact (PAH-SYMPACT) Questionnaire. The PAH-SYMPACT is a 23-item patient-reported outcome questionnaire that consists of 11 symptom items, 11 impact items, and 1 item on oxygen use. The symptom items are divided into cardiopulmonary and cardiovascular domains, and the impact items are divided into physical and emotional/cognitive domains. Symptom and impact domain scores (range 0 to 4) are calculated as the sum of the scores for the items included in the domain divided by the number of items in the domain. For all domains, a higher score indicates more severe symptoms/impacts.
Outcome measures
| Measure |
Tyvaso to TreT
n=46 Participants
Each subject received a corresponding dose of TreT for 3 weeks during the Treatment Phase based on the subject's current stable Tyvaso dose.
Treprostinil Inhalation Powder: Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)
|
|---|---|
|
Change in Patient-reported PAH Symptoms and Impact From Baseline to Week 3
Cardiopulmonary Symptoms Domain Score
|
-0.05 score on a scale
Standard Deviation 0.27
|
|
Change in Patient-reported PAH Symptoms and Impact From Baseline to Week 3
Cardiovascular Symptoms Domain Score
|
-0.06 score on a scale
Standard Deviation 0.33
|
|
Change in Patient-reported PAH Symptoms and Impact From Baseline to Week 3
Physical Impacts Domain Score
|
-0.14 score on a scale
Standard Deviation 0.46
|
|
Change in Patient-reported PAH Symptoms and Impact From Baseline to Week 3
Cognitive/Emotional Impacts Domain Score
|
-0.17 score on a scale
Standard Deviation 0.40
|
PRIMARY outcome
Timeframe: From Baseline to 11 weeks of treatment with TreTPopulation: Safety Population with PAH-SYMPACT scores at Week 11
Patient-reported PAH symptoms and impact were evaluated with the PAH Symptoms and Impact (PAH-SYMPACT) Questionnaire. The PAH-SYMPACT is a 23-item patient-reported outcome questionnaire that consists of 11 symptom items, 11 impact items, and 1 item on oxygen use. The symptom items are divided into cardiopulmonary and cardiovascular domains, and the impact items are divided into physical and emotional/cognitive domains. Symptom and impact domain scores (range 0 to 4) are calculated as the sum of the scores for the items included in the domain divided by the number of items in the domain. For all domains, a higher score indicates more severe symptoms/impacts.
Outcome measures
| Measure |
Tyvaso to TreT
n=37 Participants
Each subject received a corresponding dose of TreT for 3 weeks during the Treatment Phase based on the subject's current stable Tyvaso dose.
Treprostinil Inhalation Powder: Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)
|
|---|---|
|
Change in Patient-reported PAH Symptoms and Impact From Baseline to Week 11 (for Subjects Participating in the OEP)
Cardiopulmonary Symptoms Domain Score
|
-0.04 score on a scale
Standard Deviation 0.36
|
|
Change in Patient-reported PAH Symptoms and Impact From Baseline to Week 11 (for Subjects Participating in the OEP)
Cardiovascular Symptoms Domain Score
|
-0.05 score on a scale
Standard Deviation 0.40
|
|
Change in Patient-reported PAH Symptoms and Impact From Baseline to Week 11 (for Subjects Participating in the OEP)
Physical Impacts Domain Score
|
-0.20 score on a scale
Standard Deviation 0.59
|
|
Change in Patient-reported PAH Symptoms and Impact From Baseline to Week 11 (for Subjects Participating in the OEP)
Cognitive/Emotional Impacts Domain Score
|
-0.13 score on a scale
Standard Deviation 0.51
|
Adverse Events
Tyvaso to TreT 32 mcg (Treatment Phase)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tyvaso to TreT 48 mcg (Treatment Phase)
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Tyvaso to TreT 64 mcg (Treatment Phase)
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Tyvaso to TreT 32 mcg (Optional Extension Phase)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Tyvaso to TreT 48 mcg (Optional Extension Phase)
Serious events: 12 serious events
Other events: 25 other events
Deaths: 0 deaths
Tyvaso to TreT 64 mcg (Optional Extension Phase)
Serious events: 12 serious events
Other events: 20 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Tyvaso to TreT 32 mcg (Treatment Phase)
n=2 participants at risk
Each subject received a corresponding dose of TreT for 3 weeks during the Treatment Phase based on the subject's current stable Tyvaso dose.
Treprostinil Inhalation Powder: Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)
|
Tyvaso to TreT 48 mcg (Treatment Phase)
n=27 participants at risk
Each subject received a corresponding dose of TreT for 3 weeks during the Treatment Phase based on the subject's current stable Tyvaso dose.
Treprostinil Inhalation Powder: Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)
|
Tyvaso to TreT 64 mcg (Treatment Phase)
n=22 participants at risk
Each subject received a corresponding dose of TreT for 3 weeks during the Treatment Phase based on the subject's current stable Tyvaso dose.
Treprostinil Inhalation Powder: Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)
|
Tyvaso to TreT 32 mcg (Optional Extension Phase)
n=2 participants at risk
Each subject received a corresponding dose of TreT for 3 weeks during the Treatment Phase based on the subject's current stable Tyvaso dose.
Treprostinil Inhalation Powder: Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)
|
Tyvaso to TreT 48 mcg (Optional Extension Phase)
n=26 participants at risk
Each subject received a corresponding dose of TreT for 3 weeks during the Treatment Phase based on the subject's current stable Tyvaso dose.
Treprostinil Inhalation Powder: Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)
|
Tyvaso to TreT 64 mcg (Optional Extension Phase)
n=21 participants at risk
Each subject received a corresponding dose of TreT for 3 weeks during the Treatment Phase based on the subject's current stable Tyvaso dose.
Treprostinil Inhalation Powder: Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.5%
1/22 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.7%
1/27 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 3 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
General disorders
Chest pain
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
9.5%
2/21 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
7.7%
2/26 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Infections and infestations
Herpes simplex pneumonia
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Infections and infestations
Parotitis
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Infections and infestations
Rocky mountain spotted fever
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Infections and infestations
Sepsis
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Infections and infestations
Septic shock
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
50.0%
1/2 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
50.0%
1/2 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Injury, poisoning and procedural complications
Ureteric injury
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Investigations
Oestrogen receptor assay positive
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Metabolism and nutrition disorders
Adult failure to thrive
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Nervous system disorders
Syncope
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
7.7%
2/26 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Nervous system disorders
Seizure
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
11.5%
3/26 • Number of events 4 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
9.5%
2/21 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
50.0%
1/2 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
Other adverse events
| Measure |
Tyvaso to TreT 32 mcg (Treatment Phase)
n=2 participants at risk
Each subject received a corresponding dose of TreT for 3 weeks during the Treatment Phase based on the subject's current stable Tyvaso dose.
Treprostinil Inhalation Powder: Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)
|
Tyvaso to TreT 48 mcg (Treatment Phase)
n=27 participants at risk
Each subject received a corresponding dose of TreT for 3 weeks during the Treatment Phase based on the subject's current stable Tyvaso dose.
Treprostinil Inhalation Powder: Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)
|
Tyvaso to TreT 64 mcg (Treatment Phase)
n=22 participants at risk
Each subject received a corresponding dose of TreT for 3 weeks during the Treatment Phase based on the subject's current stable Tyvaso dose.
Treprostinil Inhalation Powder: Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)
|
Tyvaso to TreT 32 mcg (Optional Extension Phase)
n=2 participants at risk
Each subject received a corresponding dose of TreT for 3 weeks during the Treatment Phase based on the subject's current stable Tyvaso dose.
Treprostinil Inhalation Powder: Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)
|
Tyvaso to TreT 48 mcg (Optional Extension Phase)
n=26 participants at risk
Each subject received a corresponding dose of TreT for 3 weeks during the Treatment Phase based on the subject's current stable Tyvaso dose.
Treprostinil Inhalation Powder: Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)
|
Tyvaso to TreT 64 mcg (Optional Extension Phase)
n=21 participants at risk
Each subject received a corresponding dose of TreT for 3 weeks during the Treatment Phase based on the subject's current stable Tyvaso dose.
Treprostinil Inhalation Powder: Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
40.7%
11/27 • Number of events 11 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
31.8%
7/22 • Number of events 7 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
50.0%
1/2 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
15.4%
4/26 • Number of events 4 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
19.0%
4/21 • Number of events 5 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
14.8%
4/27 • Number of events 4 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
18.2%
4/22 • Number of events 4 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
100.0%
2/2 • Number of events 3 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
23.1%
6/26 • Number of events 8 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
19.0%
4/21 • Number of events 6 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
7.4%
2/27 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
9.1%
2/22 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
100.0%
2/2 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
38.5%
10/26 • Number of events 12 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
19.0%
4/21 • Number of events 4 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
7.4%
2/27 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.5%
1/22 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
100.0%
2/2 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
7.7%
2/26 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
19.0%
4/21 • Number of events 6 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
7.4%
2/27 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.5%
1/22 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
9.1%
2/22 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
50.0%
1/2 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
15.4%
4/26 • Number of events 5 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
19.0%
4/21 • Number of events 6 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
50.0%
1/2 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 3 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
9.5%
2/21 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
7.7%
2/26 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
14.3%
3/21 • Number of events 3 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
7.7%
2/26 • Number of events 3 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.5%
1/22 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
50.0%
1/2 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
15.4%
4/26 • Number of events 4 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
7.7%
2/26 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
9.5%
2/21 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
9.5%
2/21 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
9.5%
2/21 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
50.0%
1/2 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
General disorders
Fatigue
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.7%
1/27 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
7.7%
2/26 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
23.8%
5/21 • Number of events 9 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.7%
1/27 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
7.7%
2/26 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
14.3%
3/21 • Number of events 4 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
General disorders
Chest pain
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.7%
1/27 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
50.0%
1/2 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
7.7%
2/26 • Number of events 3 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
General disorders
Peripheral swelling
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
9.5%
2/21 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
General disorders
Malaise
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
9.5%
2/21 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
General disorders
Asthenia
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
50.0%
1/2 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Infections and infestations
COVID-19
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
26.9%
7/26 • Number of events 8 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
14.3%
3/21 • Number of events 3 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
50.0%
1/2 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
11.5%
3/26 • Number of events 3 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 3 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
7.7%
2/26 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
9.5%
2/21 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
9.5%
2/21 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
7.7%
2/26 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
7.7%
2/26 • Number of events 4 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.7%
1/27 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
9.5%
2/21 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
50.0%
1/2 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
9.5%
2/21 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
50.0%
1/2 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
7.7%
2/26 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
14.3%
3/21 • Number of events 5 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.7%
1/27 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
9.5%
2/21 • Number of events 4 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
7.7%
2/26 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
7.7%
2/26 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.7%
1/27 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
15.4%
4/26 • Number of events 5 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
19.0%
4/21 • Number of events 5 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
7.7%
2/26 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
19.0%
4/21 • Number of events 5 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
11.5%
3/26 • Number of events 4 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
14.3%
3/21 • Number of events 3 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Musculoskeletal and connective tissue disorders
Myaligia
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
7.7%
2/26 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
9.5%
2/21 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
7.7%
2/26 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.5%
1/22 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
50.0%
1/2 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
23.1%
6/26 • Number of events 6 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
9.5%
2/21 • Number of events 3 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
9.5%
2/21 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Nervous system disorders
Syncope
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
7.7%
2/26 • Number of events 6 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Nervous system disorders
Migraine
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
7.7%
2/26 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
15.4%
4/26 • Number of events 4 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
11.5%
3/26 • Number of events 3 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
9.5%
2/21 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
15.4%
4/26 • Number of events 5 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
15.4%
4/26 • Number of events 5 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/21 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/26 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
14.3%
3/21 • Number of events 3 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
7.7%
2/26 • Number of events 3 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/27 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
0.00%
0/22 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
50.0%
1/2 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
7.7%
2/26 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
9.5%
2/21 • Number of events 2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
|
Vascular disorders
Flushing
|
0.00%
0/2 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.7%
1/27 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.5%
1/22 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
50.0%
1/2 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
3.8%
1/26 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
4.8%
1/21 • Number of events 1 • All AEs were documented from the time of informed consent until the time screen failure was documented, until the subject either discontinued from the study, or the End of Study (EOS)/Early Termination (ET) assessments were completed, up to 201.1 weeks.
All AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, the subject was lost to further follow-up, or for at least 30 days if the AE extended beyond the EOS/ET Visit. All SAEs that occurred during the study were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final study visit.
|
Additional Information
United Therapeutics Global Medical Information
United Therapeutics Corp.
Phone: 919-485-8350
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institution and/or Principal Investigator agree not to publish or publicly present any results of the Study without the prior written consent of Sponsor, not to be unreasonably withheld or delayed. Institution and/or Principal Investigator further agree to provide Sponsor with drafts of any such publication or presentation for review and approval no less than 30 days prior to submission for publication or the date of public presentation.
- Publication restrictions are in place
Restriction type: OTHER