Trial Outcomes & Findings for An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004 (NCT NCT03596164)
NCT ID: NCT03596164
Last Updated: 2023-03-15
Results Overview
The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values)\*7. Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
11 participants
Primary outcome timeframe
Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Results posted on
2023-03-15
Participant Flow
Participants took part in the study at 5 investigative sites in Japan from 09 July 2018 to 13 January 2022.
Participants with a historical diagnosis with short bowel syndrome, who completed 24 weeks of treatment in core studies SHP633-306 (NCT03663582) or TED-C14-004 (NCT02340819) were enrolled and received teduglutide in this current study (SHP633-307). Total study duration were approximately 13 months for SHP633-306 (NCT03663582) and approximately 47 months for TED-C14-004 (NCT02340819).
Participant milestones
| Measure |
SHP633-306: Teduglutide 0.05 mg/kg
Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 milligram per kilogram (mg/kg), subcutaneous injection, once daily for up to approximately 30.3 months in this study.
|
TED-C14-004: Teduglutide 0.05 mg/kg
Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
7
|
|
Overall Study
COMPLETED
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
SHP633-306: Teduglutide 0.05 mg/kg
Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 milligram per kilogram (mg/kg), subcutaneous injection, once daily for up to approximately 30.3 months in this study.
|
TED-C14-004: Teduglutide 0.05 mg/kg
Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004
Baseline characteristics by cohort
| Measure |
SHP633-306: Teduglutide 0.05 mg/kg
n=4 Participants
Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study.
|
TED-C14-004: Teduglutide 0.05 mg/kg
n=7 Participants
Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.8 years
STANDARD_DEVIATION 12.28 • n=99 Participants
|
42.4 years
STANDARD_DEVIATION 7.21 • n=107 Participants
|
41.8 years
STANDARD_DEVIATION 8.78 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Japan
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Height
|
161.10 centimeter (cm)
STANDARD_DEVIATION 6.168 • n=99 Participants
|
167.77 centimeter (cm)
STANDARD_DEVIATION 6.735 • n=107 Participants
|
165.35 centimeter (cm)
STANDARD_DEVIATION 7.068 • n=206 Participants
|
|
Weight
|
49.29 kilogram (kg)
STANDARD_DEVIATION 10.010 • n=99 Participants
|
56.01 kilogram (kg)
STANDARD_DEVIATION 10.958 • n=107 Participants
|
53.57 kilogram (kg)
STANDARD_DEVIATION 10.660 • n=206 Participants
|
|
Body Mass Index (BMI)
|
18.96 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.441 • n=99 Participants
|
19.80 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.153 • n=107 Participants
|
19.49 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.114 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)Population: The safety population included all enrolled participants in the study.
The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values)\*7. Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Outcome measures
| Measure |
SHP633-306: Teduglutide 0.05 mg/kg
n=4 Participants
Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study.
|
TED-C14-004: Teduglutide 0.05 mg/kg
n=7 Participants
Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
Total Participants
All participants who completed SHP633-306 (NCT03663582) and were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
|---|---|---|---|
|
Number of Participants Who Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume
|
3 Participants
|
5 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)Population: The safety population included all enrolled participants in the study.
The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values)\*7. Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Outcome measures
| Measure |
SHP633-306: Teduglutide 0.05 mg/kg
n=4 Participants
Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study.
|
TED-C14-004: Teduglutide 0.05 mg/kg
n=7 Participants
Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
Total Participants
All participants who completed SHP633-306 (NCT03663582) and were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
|---|---|---|---|
|
Change From Baseline in Weekly PS Volume
|
-7.45 liter per week (L/Week)
Standard Deviation 7.908
|
-8.67 liter per week (L/Week)
Standard Deviation 7.450
|
—
|
PRIMARY outcome
Timeframe: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)Population: The safety population included all enrolled participants in the study.
The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values)\*7. Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Outcome measures
| Measure |
SHP633-306: Teduglutide 0.05 mg/kg
n=4 Participants
Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study.
|
TED-C14-004: Teduglutide 0.05 mg/kg
n=7 Participants
Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
Total Participants
All participants who completed SHP633-306 (NCT03663582) and were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
|---|---|---|---|
|
Percent Change From Baseline in Weekly PS Volume
|
-49.55 percent change
Standard Deviation 41.411
|
-52.52 percent change
Standard Deviation 39.828
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)Population: The safety population included all enrolled participants in the study.
Outcome measures
| Measure |
SHP633-306: Teduglutide 0.05 mg/kg
n=4 Participants
Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study.
|
TED-C14-004: Teduglutide 0.05 mg/kg
n=7 Participants
Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
Total Participants
All participants who completed SHP633-306 (NCT03663582) and were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
|---|---|---|---|
|
Number of Participants Who Were Completely Weaned Off PS at End of Study (EOS)
|
1 Participants
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)Population: The safety population included all enrolled participants in the study.
Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Outcome measures
| Measure |
SHP633-306: Teduglutide 0.05 mg/kg
n=4 Participants
Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study.
|
TED-C14-004: Teduglutide 0.05 mg/kg
n=7 Participants
Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
Total Participants
All participants who completed SHP633-306 (NCT03663582) and were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
|---|---|---|---|
|
Change From Baseline in Days Per Week of PS
|
-2.3 days per week
Standard Deviation 3.30
|
-2.0 days per week
Standard Deviation 3.42
|
—
|
PRIMARY outcome
Timeframe: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)Population: The safety population included all enrolled participants in the study.
Plasma citrulline was measured as an assessment of enterocyte mass. Plasma samples were analyzed using a validated high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Outcome measures
| Measure |
SHP633-306: Teduglutide 0.05 mg/kg
n=4 Participants
Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study.
|
TED-C14-004: Teduglutide 0.05 mg/kg
n=7 Participants
Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
Total Participants
All participants who completed SHP633-306 (NCT03663582) and were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
|---|---|---|---|
|
Change From Baseline in Plasma Citrulline Levels
|
12.96 micromoles per liter
Standard Deviation 5.568
|
19.15 micromoles per liter
Standard Deviation 18.851
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)Population: The safety population included all enrolled participants in the study.
Outcome measures
| Measure |
SHP633-306: Teduglutide 0.05 mg/kg
n=4 Participants
Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study.
|
TED-C14-004: Teduglutide 0.05 mg/kg
n=7 Participants
Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
Total Participants
n=11 Participants
All participants who completed SHP633-306 (NCT03663582) and were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TEAE
|
4 Participants
|
7 Participants
|
11 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
TESAE
|
3 Participants
|
4 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)Population: The safety population included all enrolled participants in the study.
Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Outcome measures
| Measure |
SHP633-306: Teduglutide 0.05 mg/kg
n=4 Participants
Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study.
|
TED-C14-004: Teduglutide 0.05 mg/kg
n=7 Participants
Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
Total Participants
n=11 Participants
All participants who completed SHP633-306 (NCT03663582) and were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)Population: The safety population included all enrolled participants in the study.
Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Outcome measures
| Measure |
SHP633-306: Teduglutide 0.05 mg/kg
n=4 Participants
Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study.
|
TED-C14-004: Teduglutide 0.05 mg/kg
n=7 Participants
Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
Total Participants
n=11 Participants
All participants who completed SHP633-306 (NCT03663582) and were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)Population: The safety population included all enrolled participants in the study.
Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Outcome measures
| Measure |
SHP633-306: Teduglutide 0.05 mg/kg
n=4 Participants
Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study.
|
TED-C14-004: Teduglutide 0.05 mg/kg
n=7 Participants
Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
Total Participants
n=11 Participants
All participants who completed SHP633-306 (NCT03663582) and were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Laboratory Values
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)Population: The safety population included all enrolled participants in the study.
Outcome measures
| Measure |
SHP633-306: Teduglutide 0.05 mg/kg
n=4 Participants
Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study.
|
TED-C14-004: Teduglutide 0.05 mg/kg
n=7 Participants
Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
Total Participants
n=11 Participants
All participants who completed SHP633-306 (NCT03663582) and were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
|---|---|---|---|
|
Number of Participants Who Reported Positive Specific Antibodies to Teduglutide at EOS
|
3 Participants
|
4 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)Population: The safety population included all enrolled participants in the study.
Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Outcome measures
| Measure |
SHP633-306: Teduglutide 0.05 mg/kg
n=4 Participants
Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study.
|
TED-C14-004: Teduglutide 0.05 mg/kg
n=7 Participants
Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
Total Participants
n=11 Participants
All participants who completed SHP633-306 (NCT03663582) and were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
|---|---|---|---|
|
Change From Baseline in 48-Hour Urine Output
|
428.8 Milliliter per day (mL/day)
Standard Deviation 286.57
|
308.6 Milliliter per day (mL/day)
Standard Deviation 589.36
|
352.3 Milliliter per day (mL/day)
Standard Deviation 486.54
|
PRIMARY outcome
Timeframe: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)Population: The safety population included all enrolled participants in the study.
Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Outcome measures
| Measure |
SHP633-306: Teduglutide 0.05 mg/kg
n=4 Participants
Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study.
|
TED-C14-004: Teduglutide 0.05 mg/kg
n=7 Participants
Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
Total Participants
n=11 Participants
All participants who completed SHP633-306 (NCT03663582) and were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Body Weight Measurements
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)Population: The safety population included all enrolled participants in the study.
Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Outcome measures
| Measure |
SHP633-306: Teduglutide 0.05 mg/kg
n=4 Participants
Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study.
|
TED-C14-004: Teduglutide 0.05 mg/kg
n=7 Participants
Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
Total Participants
n=11 Participants
All participants who completed SHP633-306 (NCT03663582) and were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in BMI
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)Population: The safety population included all enrolled participants in the study.
Outcome measures
| Measure |
SHP633-306: Teduglutide 0.05 mg/kg
n=4 Participants
Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study.
|
TED-C14-004: Teduglutide 0.05 mg/kg
n=7 Participants
Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
Total Participants
n=11 Participants
All participants who completed SHP633-306 (NCT03663582) and were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Colonoscopy/Sigmoidoscopy Results
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
SHP633-306: Teduglutide 0.05 mg/kg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
TED-C14-004: Teduglutide 0.05 mg/kg
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Total Participants
Serious events: 7 serious events
Other events: 11 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
SHP633-306: Teduglutide 0.05 mg/kg
n=4 participants at risk
Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study.
|
TED-C14-004: Teduglutide 0.05 mg/kg
n=7 participants at risk
Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
Total Participants
n=11 participants at risk
All participants who completed SHP633-306 (NCT03663582) and were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Product Issues
Device breakage
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Product Issues
Device occlusion
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
57.1%
4/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
36.4%
4/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Epilepsy
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Hepatic failure
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pyrexia
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Sepsis
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Subclavian vein occlusion
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
SHP633-306: Teduglutide 0.05 mg/kg
n=4 participants at risk
Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study.
|
TED-C14-004: Teduglutide 0.05 mg/kg
n=7 participants at risk
Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
Total Participants
n=11 participants at risk
All participants who completed SHP633-306 (NCT03663582) and were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Anal abscess
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Anal erosion
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Catheter site pain
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cellulitis
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Device related infection
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Haematuria
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Herpes zoster
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
50.0%
2/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
27.3%
3/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Influenza
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
42.9%
3/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
36.4%
4/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
50.0%
2/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
42.9%
3/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
45.5%
5/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Selenium deficiency
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Somnolence
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Vaccination site pain
|
25.0%
1/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • TEAEs were defined as AEs that started on or after the first dose of study drug (in current study) up to approximately 42 months
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER