Trial Outcomes & Findings for Trial of NanoPac Intratumoral Injection in Lung Cancer (NCT NCT04314895)
NCT ID: NCT04314895
Last Updated: 2025-05-23
Results Overview
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Day 1 to Week 24 (6 Months)
Results posted on
2025-05-23
Participant Flow
Participant milestones
| Measure |
NanoPac 15 mg/mL
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
One Injection
|
3
|
|
Overall Study
Two Injections
|
5
|
|
Overall Study
Three Injections
|
10
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
NanoPac 15 mg/mL
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Death
|
10
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Trial of NanoPac Intratumoral Injection in Lung Cancer
Baseline characteristics by cohort
| Measure |
NanoPac 15 mg/mL
n=18 Participants
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart.
|
|---|---|
|
Age, Continuous
Age
|
68.4 years
STANDARD_DEVIATION 9.2 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Type of Lung Cancer
Adenocarcinoma
|
8 Participants
n=99 Participants
|
|
Type of Lung Cancer
Squamous cell carcinoma
|
10 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Week 24 (6 Months)Population: All subjects enrolled provided data for this outcome measure. Of the 18 subjects enrolled, one subject in the "NanoPac 15 mg/ml - One Injection" arm was determined to have non-malignant disease after pathology review following initial injection with NanoPac, and this subject is therefore not included in efficacy assessments but was included in the outcome measure of number of participants with treatment emergent adverse events.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
Outcome measures
| Measure |
NanoPac 15 mg/mL
n=18 Participants
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart.
|
NanoPac 15 mg/mL - Two Injections
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart. These subjects received two of the optional three NanoPac injections.
|
NanoPac 15 mg/mL - Three Injections
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart. These subjects received all three of the optional NanoPac injections.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
|
18 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Weeks 1, 2, 4, 5, 6, 8, 9, 10, 12, 18, and 24Population: Of the 18 subjects enrolled, one subject in the "NanoPac 15 mg/ml - One Injection" arm was determined to have non-malignant disease after pathology review following initial injection with NanoPac, and this subject is therefore not included in efficacy assessments but was included in the outcome measure of concentration of paclitaxel in the systemic circulation post-injection. The remaining two subjects in the "NanoPac 15 mg/ml - One Injection" arm discontinued from the study prior to Week 12.
To characterize the pharmacokinetics of intratumoral NanoPac, plasma samples were taken on days of NanoPac injection prior to injection and at 1, 2, and 4 hours after NanoPac injection, as well as at all other study visits up through Week 24. Plasma paclitaxel concentrations are reported in pg/mL.
Outcome measures
| Measure |
NanoPac 15 mg/mL
n=3 Participants
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart.
|
NanoPac 15 mg/mL - Two Injections
n=5 Participants
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart. These subjects received two of the optional three NanoPac injections.
|
NanoPac 15 mg/mL - Three Injections
n=10 Participants
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart. These subjects received all three of the optional NanoPac injections.
|
|---|---|---|---|
|
Concentration of Paclitaxel in the Systemic Circulation Post-injection
Day 1 - Pre-Injection
|
566.7 pg/mL
Standard Deviation 981.50
|
44.2 pg/mL
Standard Deviation 82.61
|
32.8 pg/mL
Standard Deviation 103.72
|
|
Concentration of Paclitaxel in the Systemic Circulation Post-injection
Day 1 - 1 Hr Post-Injection
|
10685.0 pg/mL
Standard Deviation 3415.33
|
24104.0 pg/mL
Standard Deviation 28642.55
|
45523.7 pg/mL
Standard Deviation 93639.03
|
|
Concentration of Paclitaxel in the Systemic Circulation Post-injection
Day 1 - 2 Hr Post-Injection
|
6470.0 pg/mL
Standard Deviation 2757.72
|
21850.0 pg/mL
Standard Deviation 20982.28
|
27678.1 pg/mL
Standard Deviation 49332.88
|
|
Concentration of Paclitaxel in the Systemic Circulation Post-injection
Day 1 - 4 Hr Post-Injection
|
4360.0 pg/mL
Standard Deviation 1767.77
|
9877.5 pg/mL
Standard Deviation 8798.58
|
25884.8 pg/mL
Standard Deviation 46389.73
|
|
Concentration of Paclitaxel in the Systemic Circulation Post-injection
Week 1
|
2070.0 pg/mL
Standard Deviation NA
Only 1 subject provided plasma in this group at this timepoint
|
3232.0 pg/mL
Standard Deviation 2284.86
|
2399.3 pg/mL
Standard Deviation 3981.41
|
|
Concentration of Paclitaxel in the Systemic Circulation Post-injection
Week 2
|
810.0 pg/mL
Standard Deviation 1145.51
|
1739.0 pg/mL
Standard Deviation 2011.08
|
10215.3 pg/mL
Standard Deviation 28268.21
|
|
Concentration of Paclitaxel in the Systemic Circulation Post-injection
Week 4 - Pre-Injection
|
0.0 pg/mL
Standard Deviation NA
Only 1 subject provided plasma in this group at this timepoint
|
2125.3 pg/mL
Standard Deviation 2056.14
|
863.7 pg/mL
Standard Deviation 1319.34
|
|
Concentration of Paclitaxel in the Systemic Circulation Post-injection
Week 5
|
—
|
2662.0 pg/mL
Standard Deviation 1977.22
|
1933.5 pg/mL
Standard Deviation 3036.68
|
|
Concentration of Paclitaxel in the Systemic Circulation Post-injection
Week 6
|
1060.0 pg/mL
Standard Deviation NA
Only 1 subject provided plasma in this group at this timepoint
|
21640.0 pg/mL
Standard Deviation 28369.12
|
1357.1 pg/mL
Standard Deviation 2031.87
|
|
Concentration of Paclitaxel in the Systemic Circulation Post-injection
Week 8 - Pre-Injection
|
0.0 pg/mL
Standard Deviation NA
Only 1 subject provided plasma in this group at this timepoint
|
7976.3 pg/mL
Standard Deviation 12147.98
|
702.5 pg/mL
Standard Deviation 1171.64
|
|
Concentration of Paclitaxel in the Systemic Circulation Post-injection
Week 9
|
—
|
17695.0 pg/mL
Standard Deviation 16977.63
|
1951.5 pg/mL
Standard Deviation 4991.29
|
|
Concentration of Paclitaxel in the Systemic Circulation Post-injection
Week 10
|
—
|
11900.0 pg/mL
Standard Deviation NA
Only 1 subject provided plasma in this group at this timepoint
|
1813.1 pg/mL
Standard Deviation 2291.70
|
|
Concentration of Paclitaxel in the Systemic Circulation Post-injection
Week 12
|
667.0 pg/mL
Standard Deviation NA
Only 1 subject provided plasma in this group at this timepoint
|
7953.5 pg/mL
Standard Deviation 10955.21
|
551.9 pg/mL
Standard Deviation 980.98
|
|
Concentration of Paclitaxel in the Systemic Circulation Post-injection
Week 18
|
0.0 pg/mL
Standard Deviation NA
Only 1 subject provided plasma in this group at this timepoint
|
4910.5 pg/mL
Standard Deviation 6801.66
|
80.7 pg/mL
Standard Deviation 176.92
|
|
Concentration of Paclitaxel in the Systemic Circulation Post-injection
Week 24
|
589.0 pg/mL
Standard Deviation NA
Only 1 subject provided plasma in this group at this timepoint
|
5770.1 pg/mL
Standard Deviation 8103.37
|
10.6 pg/mL
Standard Deviation 23.75
|
SECONDARY outcome
Timeframe: Weeks 24, 38, and 52Population: Of the 18 subjects enrolled, one subject was determined to have non-malignant disease after pathology review following initial injection with NanoPac, and this subject is therefore not included in efficacy assessments i.e. PFS.
Progression free survival (PFS) as assessed using RECIST v1.1
Outcome measures
| Measure |
NanoPac 15 mg/mL
n=2 Participants
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart.
|
NanoPac 15 mg/mL - Two Injections
n=5 Participants
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart. These subjects received two of the optional three NanoPac injections.
|
NanoPac 15 mg/mL - Three Injections
n=10 Participants
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart. These subjects received all three of the optional NanoPac injections.
|
|---|---|---|---|
|
Progression Free Survival (PFS)
Week 24 · Progression Free
|
0 Participants
|
0 Participants
|
5 Participants
|
|
Progression Free Survival (PFS)
Week 24 · Progressed or Died
|
2 Participants
|
5 Participants
|
4 Participants
|
|
Progression Free Survival (PFS)
Week 24 · Censored
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Progression Free Survival (PFS)
Week 38 · Progression Free
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Progression Free Survival (PFS)
Week 38 · Progressed or Died
|
2 Participants
|
5 Participants
|
5 Participants
|
|
Progression Free Survival (PFS)
Week 38 · Censored
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Progression Free Survival (PFS)
Week 52 · Progression Free
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Progression Free Survival (PFS)
Week 52 · Progressed or Died
|
2 Participants
|
5 Participants
|
6 Participants
|
|
Progression Free Survival (PFS)
Week 52 · Censored
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Weeks 24, 38, and 52Population: Of the 18 subjects enrolled, one subject was determined to have non-malignant disease after pathology review following initial injection with NanoPac, and this subject is therefore not included in efficacy assessments i.e. overall survival.
Overall survival (OS) as determined by survival time following first NanoPac injection
Outcome measures
| Measure |
NanoPac 15 mg/mL
n=2 Participants
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart.
|
NanoPac 15 mg/mL - Two Injections
n=5 Participants
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart. These subjects received two of the optional three NanoPac injections.
|
NanoPac 15 mg/mL - Three Injections
n=10 Participants
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart. These subjects received all three of the optional NanoPac injections.
|
|---|---|---|---|
|
Overall Survival
Week 52 · Dead
|
1 Participants
|
3 Participants
|
6 Participants
|
|
Overall Survival
Week 24 · Confirmed Alive
|
0 Participants
|
3 Participants
|
6 Participants
|
|
Overall Survival
Week 24 · Dead
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Overall Survival
Week 24 · Censored
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Overall Survival
Week 38 · Confirmed Alive
|
0 Participants
|
3 Participants
|
4 Participants
|
|
Overall Survival
Week 38 · Dead
|
1 Participants
|
2 Participants
|
5 Participants
|
|
Overall Survival
Week 38 · Censored
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Overall Survival
Week 52 · Confirmed Alive
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Overall Survival
Week 52 · Censored
|
1 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 38, and 52Population: Of the 18 subjects enrolled, one subject in the "NanoPac 15 mg/ml - One Injection" arm was determined to have non-malignant disease after pathology review following initial injection with NanoPac, and this subject is therefore not included in efficacy assessments, i.e. change in tumor dimensions (longest diameter). The remaining two subjects in the "NanoPac 15 mg/ml - One Injection" arm discontinued from the study prior to Week 12.
Change in longest dimension (cm) as determined by CT imaging compared to baseline (Screening)
Outcome measures
| Measure |
NanoPac 15 mg/mL
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart.
|
NanoPac 15 mg/mL - Two Injections
n=5 Participants
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart. These subjects received two of the optional three NanoPac injections.
|
NanoPac 15 mg/mL - Three Injections
n=10 Participants
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart. These subjects received all three of the optional NanoPac injections.
|
|---|---|---|---|
|
Change in Tumor Dimensions (Longest Diameter)
Week 52 - Change from Baseline
|
—
|
1.62 cm
Standard Deviation NA
Data available from only one subject
|
-0.91 cm
Standard Deviation 0.753
|
|
Change in Tumor Dimensions (Longest Diameter)
Week 12 - Change from Baseline
|
—
|
2.06 cm
Standard Deviation 2.913
|
-0.23 cm
Standard Deviation 0.907
|
|
Change in Tumor Dimensions (Longest Diameter)
Week 24 - Change from Baseline
|
—
|
1.26 cm
Standard Deviation 1.216
|
-0.78 cm
Standard Deviation 0.678
|
|
Change in Tumor Dimensions (Longest Diameter)
Week 38 - Change from Baseline
|
—
|
1.0 cm
Standard Deviation NA
Data available from only one subject
|
-0.85 cm
Standard Deviation 0.635
|
Adverse Events
NanoPac 15 mg/mL - One Injection
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
NanoPac 15 mg/mL - Two Injections
Serious events: 3 serious events
Other events: 5 other events
Deaths: 3 deaths
NanoPac 15 mg/mL - Three Injections
Serious events: 7 serious events
Other events: 10 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
NanoPac 15 mg/mL - One Injection
n=3 participants at risk
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart. These subjects received only one of the optional three NanoPac injections.
|
NanoPac 15 mg/mL - Two Injections
n=5 participants at risk
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart. These subjects received two of the optional three NanoPac injections.
|
NanoPac 15 mg/mL - Three Injections
n=10 participants at risk
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart. These subjects received all three of the optional NanoPac injections.
|
|---|---|---|---|
|
Cardiac disorders
Cardio-respiratory arrest
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Acute interstitial pneumonitis
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
General disorders
Disease progression
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
2/10 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
General disorders
Death
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Cardiac disorders
Fluid overload
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
Other adverse events
| Measure |
NanoPac 15 mg/mL - One Injection
n=3 participants at risk
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart. These subjects received only one of the optional three NanoPac injections.
|
NanoPac 15 mg/mL - Two Injections
n=5 participants at risk
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart. These subjects received two of the optional three NanoPac injections.
|
NanoPac 15 mg/mL - Three Injections
n=10 participants at risk
Intratumoral injection of NanoPac 15 mg/mL at a volume of up to 20% of the total calculated tumor and lymph node volume (not to exceed 40 mL) on up to three occasions 4 weeks apart. These subjects received all three of the optional NanoPac injections.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
2/10 • Number of events 3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Cardiac disorders
Cardiac failure
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Endocrine disorders
Adrenal mass
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Eye disorders
Diplopia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Eye disorders
Eye pruritus
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
40.0%
2/5 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
40.0%
4/10 • Number of events 7 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
50.0%
5/10 • Number of events 5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
2/10 • Number of events 3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
General disorders
Asthenia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
General disorders
Chills
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
60.0%
3/5 • Number of events 3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
40.0%
4/10 • Number of events 4 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
General disorders
Feeling abnormal
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
2/10 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Hepatobiliary disorders
Hepatic lesion
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Infections and infestations
Bronchitis
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
2/10 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
50.0%
5/10 • Number of events 6 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Infections and infestations
Systemic candida
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
2/10 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Injury, poisoning and procedural complications
Post procedural oedema
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
40.0%
2/5 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
2/10 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
60.0%
3/5 • Number of events 3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
2/10 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
2/10 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
2/10 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Musculoskeletal and connective tissue disorders
Clubbing
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Psychiatric disorders
Mental status changed
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
2/10 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
40.0%
2/5 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
30.0%
3/10 • Number of events 3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
40.0%
2/5 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
40.0%
2/5 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
2/10 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
2/10 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
2/10 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
2/10 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
60.0%
3/5 • Number of events 3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
2/10 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
2/10 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
40.0%
2/5 • Number of events 2 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/5 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
10.0%
1/10 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
20.0%
1/5 • Number of events 1 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
0.00%
0/10 • All-Cause Mortality was assessed through study completion, up to 52 weeks; all adverse events were collected from the time of dosing until Week 24.
AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place