Trial Outcomes & Findings for CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIAL (NCT NCT03907241)
NCT ID: NCT03907241
Last Updated: 2020-10-27
Results Overview
Number of TEAEs
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
27 participants
Primary outcome timeframe
From study start to end, up to 3.5 years
Results posted on
2020-10-27
Participant Flow
Participant milestones
| Measure |
Octanorm 16.5%
octanorm 16.5%, human normal immunoglobulin for subcutaneous (SC) administration.
Octanorm 16.5%: Human normal immunoglobulin
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIAL
Baseline characteristics by cohort
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=17 Participants
Octanorm 16.5%
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
6.50 years
n=5 Participants
|
9.00 years
n=7 Participants
|
14.25 years
n=5 Participants
|
56.12 years
n=4 Participants
|
39.26 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
ABO Rhesus Blood Type
A Blood Type
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
ABO Rhesus Blood Type
AB Blood Type
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
ABO Rhesus Blood Type
O Blood Type
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From study start to end, up to 3.5 yearsNumber of TEAEs
Outcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=17 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
Occurrence of All Treatment-emergent Adverse Events (TEAEs)
TEAEs excluding infections
|
8 events
|
19 events
|
22 events
|
155 events
|
|
Occurrence of All Treatment-emergent Adverse Events (TEAEs)
Infections
|
8 events
|
12 events
|
22 events
|
77 events
|
PRIMARY outcome
Timeframe: From study start to end, up to 3.5 yearsOutcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=17 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
Occurrence of Temporally Associated TEAEs
Temporally Associated TEAEs excluding infections
|
2 events
|
7 events
|
13 events
|
72 events
|
|
Occurrence of Temporally Associated TEAEs
Temporally Associated Infections
|
5 events
|
6 events
|
11 events
|
45 events
|
PRIMARY outcome
Timeframe: From study start to end, up to 3.5 yearsNumber of temporally associated TEAEs by infusion rate. Only includes systemic TEAEs without infections and without infusion site reactions
Outcome measures
| Measure |
Age >=2 to <6
n=2 infusions
Octanorm 16.5%
|
Age >=6 to <12
n=7 infusions
Octanorm 16.5%
|
Age >=12 to <17
n=13 infusions
Octanorm 16.5%
|
Age >=17 to <=75
n=72 infusions
Octanorm 16.5%
|
|---|---|---|---|---|
|
Number of Temporally Associated TEAEs by Infusion Rate
30 to <40ml/hr
|
0 infusions
|
6 infusions
|
0 infusions
|
6 infusions
|
|
Number of Temporally Associated TEAEs by Infusion Rate
60 to <70ml/hr
|
0 infusions
|
0 infusions
|
0 infusions
|
2 infusions
|
|
Number of Temporally Associated TEAEs by Infusion Rate
70 to <80ml/hr
|
0 infusions
|
0 infusions
|
0 infusions
|
4 infusions
|
|
Number of Temporally Associated TEAEs by Infusion Rate
missing
|
0 infusions
|
0 infusions
|
0 infusions
|
1 infusions
|
|
Number of Temporally Associated TEAEs by Infusion Rate
10 to <20ml/h
|
1 infusions
|
0 infusions
|
0 infusions
|
0 infusions
|
|
Number of Temporally Associated TEAEs by Infusion Rate
20 to <30ml/hr
|
1 infusions
|
1 infusions
|
0 infusions
|
0 infusions
|
|
Number of Temporally Associated TEAEs by Infusion Rate
40 to <50ml/hr
|
0 infusions
|
0 infusions
|
9 infusions
|
28 infusions
|
|
Number of Temporally Associated TEAEs by Infusion Rate
50 to <60ml/hr
|
0 infusions
|
0 infusions
|
4 infusions
|
3 infusions
|
|
Number of Temporally Associated TEAEs by Infusion Rate
80 to <90ml/hr
|
0 infusions
|
0 infusions
|
0 infusions
|
6 infusions
|
|
Number of Temporally Associated TEAEs by Infusion Rate
90 to <100ml/hr
|
0 infusions
|
0 infusions
|
0 infusions
|
22 infusions
|
PRIMARY outcome
Timeframe: From study start to end, up to 3.5 yearsOutcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=17 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
Local Injection-site Reactions
|
0 infusion site reactions
|
4 infusion site reactions
|
3 infusion site reactions
|
5 infusion site reactions
|
PRIMARY outcome
Timeframe: From study start to end, up to 3.5 yearsSystolic and diastolic.
Outcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=17 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
Blood Pressure
Systolic Blood Pressure End of Study
|
102.50 mmHg
Standard Deviation 0.707
|
103.00 mmHg
Standard Deviation 12.302
|
114.00 mmHg
Standard Deviation 16.104
|
127.24 mmHg
Standard Deviation 12.553
|
|
Blood Pressure
Diastolic Blood Pressure at Screening
|
63.00 mmHg
Standard Deviation 11.314
|
62.25 mmHg
Standard Deviation 6.551
|
68.50 mmHg
Standard Deviation 2.380
|
78.79 mmHg
Standard Deviation 9.407
|
|
Blood Pressure
Systolic Blood Pressure at Screening
|
100.00 mmHg
Standard Deviation 2.828
|
105.00 mmHg
Standard Deviation 7.789
|
116.60 mmHg
Standard Deviation 6.758
|
126.21 mmHg
Standard Deviation 15.817
|
|
Blood Pressure
Diastolic Blood Pressure at End of Study
|
58.50 mmHg
Standard Deviation 13.435
|
63.75 mmHg
Standard Deviation 6.702
|
70.25 mmHg
Standard Deviation 12.842
|
73.71 mmHg
Standard Deviation 8.130
|
PRIMARY outcome
Timeframe: From study start to end, up to 3.5 yearsOutcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=14 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
Body Temperature
Temperature at Screening
|
36.85 degrees Celsius
Standard Deviation 0.071
|
36.98 degrees Celsius
Standard Deviation 0.287
|
36.63 degrees Celsius
Standard Deviation 0.359
|
36.56 degrees Celsius
Standard Deviation 0.298
|
|
Body Temperature
Temperature at End of Study
|
36.55 degrees Celsius
Standard Deviation 0.354
|
36.58 degrees Celsius
Standard Deviation 0.377
|
36.65 degrees Celsius
Standard Deviation 0.129
|
36.57 degrees Celsius
Standard Deviation 0.355
|
PRIMARY outcome
Timeframe: From study start to end, up to 3.5 yearsPopulation: Not all recorded
Outcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=17 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
Respiratory Rate
Respiratory Rate at Screening
|
23.50 breaths/minute
Standard Deviation 6.364
|
19.00 breaths/minute
Standard Deviation 3.830
|
16.00 breaths/minute
Standard Deviation 0.000
|
16.07 breaths/minute
Standard Deviation 2.129
|
|
Respiratory Rate
Respiratory Rate at End of Study
|
17.50 breaths/minute
Standard Deviation 2.121
|
15.50 breaths/minute
Standard Deviation 1.000
|
17.75 breaths/minute
Standard Deviation 2.630
|
16.47 breaths/minute
Standard Deviation 2.625
|
PRIMARY outcome
Timeframe: From study start to end, up to 3.5 yearsPopulation: Not all assessed during visits
Changes in sodium levels from baseline to end of study
Outcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=17 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
Sodium
|
0.50 mmol/L
Standard Deviation 0.707
|
0.25 mmol/L
Standard Deviation 1.258
|
1.75 mmol/L
Standard Deviation 2.217
|
0.41 mmol/L
Standard Deviation 2.238
|
PRIMARY outcome
Timeframe: From study start to end, up to 3.5 yearsChanges in potassium levels from baseline to end of study
Outcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=17 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
Potassium
|
0.35 mmol/L
Standard Deviation 0.354
|
0.25 mmol/L
Standard Deviation 0.300
|
0.18 mmol/L
Standard Deviation 0.340
|
-0.05 mmol/L
Standard Deviation 0.726
|
PRIMARY outcome
Timeframe: From study start to end, up to 3.5 yearsChanges in blood glucose from baseline to end of study
Outcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=17 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
Blood Glucose
|
-1.03 mmol/L
Standard Deviation 1.766
|
3.49 mmol/L
Standard Deviation 9.017
|
0.22 mmol/L
Standard Deviation 0.371
|
-0.69 mmol/L
Standard Deviation 1.672
|
PRIMARY outcome
Timeframe: From study start to end, up to 3.5 yearsChanges in ALAT (alanine transaminase) from baseline to end of study
Outcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=17 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
ALAT
|
-2.50 U/L
Standard Deviation 2.121
|
-5.75 U/L
Standard Deviation 8.016
|
-1.50 U/L
Standard Deviation 16.135
|
0.71 U/L
Standard Deviation 4.074
|
PRIMARY outcome
Timeframe: From study start to end, up to 3.5 yearsChanges in ASAT (aspartate aminotransferase) from baseline to end of study
Outcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=17 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
ASAT
|
-3.00 U/L
Standard Deviation 7.071
|
-4.00 U/L
Standard Deviation 5.354
|
-3.00 U/L
Standard Deviation 11.633
|
0.59 U/L
Standard Deviation 5.885
|
PRIMARY outcome
Timeframe: From study start to end, up to 3.5 yearsChanges in LDH (lactate dehydrogenase) from baseline to end of study
Outcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=17 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
LDH
|
23.50 U/L
Standard Deviation 60.104
|
-110.50 U/L
Standard Deviation 131.751
|
-52.50 U/L
Standard Deviation 41.348
|
-8.47 U/L
Standard Deviation 26.779
|
PRIMARY outcome
Timeframe: From study start to end, up to 3.5 yearsChanges in total bilirubin from baseline to end of study
Outcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=17 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
Total Bilirubin
|
0.86 umol/L
Standard Deviation 1.209
|
0.94 umol/L
Standard Deviation 1.095
|
1.58 umol/L
Standard Deviation 2.309
|
0.52 umol/L
Standard Deviation 2.793
|
PRIMARY outcome
Timeframe: From study start to end, up to 3.5 yearsChanges in blood urea nitrogen from baseline to end of study
Outcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=11 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
Blood Urea Nitrogen
|
0.36 mmol/L
Standard Deviation 1.010
|
-2.12 mmol/L
Standard Deviation 3.124
|
0.09 mmol/L
Standard Deviation 1.468
|
-0.49 mmol/L
Standard Deviation 1.154
|
PRIMARY outcome
Timeframe: From study start to end, up to 3.5 yearsChanges in creatinine from baseline to end of study
Outcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=17 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
Creatinine
|
-4.86 umol/L
Standard Deviation 5.626
|
-27.72 umol/L
Standard Deviation 54.837
|
4.20 umol/L
Standard Deviation 6.431
|
-0.62 umol/L
Standard Deviation 10.959
|
PRIMARY outcome
Timeframe: From study start to end, up to 3.5 yearsChanges in urine pH from baseline to end of study
Outcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=16 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
Urine pH
|
0.00 pH
Standard Deviation 1.414
|
0.13 pH
Standard Deviation 2.056
|
-0.50 pH
Standard Deviation 0.913
|
-0.34 pH
Standard Deviation 0.889
|
PRIMARY outcome
Timeframe: From study start to end, up to 3.5 yearsNumber of Participants with a Change in Urine Glucose
Outcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=17 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
Number of Participants With a Change in Urine Glucose
From Normal to Normal
|
2 Participants
|
4 Participants
|
4 Participants
|
15 Participants
|
|
Number of Participants With a Change in Urine Glucose
From High Non-CS to Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With a Change in Urine Glucose
Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From study start to end, up to 3.5 yearsNumber of Participants With a Change in Urine Ketones at baseline and end of study
Outcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=17 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
Number of Participants With a Change in Urine Ketones
From Normal to High Non-CS
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With a Change in Urine Ketones
From High Non-CS to Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With a Change in Urine Ketones
From High Non-CS to Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With a Change in Urine Ketones
From Normal to Normal
|
2 Participants
|
4 Participants
|
4 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: From study start to end, up to 3.5 yearsNumber of participants with a change in urine leukocytes at baseline and end of study
Outcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=17 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
Number of Participants With a Change in Urine Leukocytes
From Normal to Normal
|
2 Participants
|
3 Participants
|
4 Participants
|
14 Participants
|
|
Number of Participants With a Change in Urine Leukocytes
From Normal to High Non-CS
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With a Change in Urine Leukocytes
From Normal to Missing
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From study start to end, up to 3.5 yearsNumber of participants with a change in urine hemoglobin at baseline and end of study
Outcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=17 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
Number of Participants With a Change in Urine Hemoglobin
From Normal to Normal
|
2 Participants
|
4 Participants
|
4 Participants
|
14 Participants
|
|
Number of Participants With a Change in Urine Hemoglobin
From Normal to High Non-CS
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With a Change in Urine Hemoglobin
From High Non-CS to Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With a Change in Urine Hemoglobin
From High Non-CS to Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From study start to end, up to 3.5 yearsChanges in complete red blood cell count from baseline to end of study
Outcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=17 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
Complete Red Blood Cell Count
|
0.14 10^12 cells/L
Standard Deviation 0.311
|
-0.06 10^12 cells/L
Standard Deviation 0.256
|
0.17 10^12 cells/L
Standard Deviation 0.321
|
0.01 10^12 cells/L
Standard Deviation 0.287
|
PRIMARY outcome
Timeframe: From study start to end, up to 3.5 yearsChanges in haematocrit from baseline to end of study
Outcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=17 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
Haematocrit
|
0.02 L/L
Standard Deviation 0.034
|
0.00 L/L
Standard Deviation 0.013
|
0.02 L/L
Standard Deviation 0.032
|
0.00 L/L
Standard Deviation 0.030
|
PRIMARY outcome
Timeframe: From study start to end, up to 3.5 yearsChanges in haemoglobin from baseline to end of study
Outcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=17 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
Haemoglobin
|
8.00 g/L
Standard Deviation 7.071
|
-2.08 g/L
Standard Deviation 4.198
|
4.25 g/L
Standard Deviation 11.673
|
1.29 g/L
Standard Deviation 8.513
|
PRIMARY outcome
Timeframe: From study start to end, up to 3.5 yearsChanges in complete white blood cell count from baseline to end of study
Outcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=17 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
Complete White Blood Cell Count
|
1.45 10^9 cells/L
Standard Deviation 1.626
|
-0.05 10^9 cells/L
Standard Deviation 1.034
|
0.40 10^9 cells/L
Standard Deviation 1.655
|
-0.24 10^9 cells/L
Standard Deviation 1.722
|
SECONDARY outcome
Timeframe: From study start to end, up to 3.5 yearsPopulation: Not all collected
Measurement of trough total IgG levels from baseline to end of study
Outcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=17 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
Measurement of Trough Total IgG Levels
IgG at End of Study
|
12.50 g/L
Standard Deviation 3.048
|
15.45 g/L
Standard Deviation 7.359
|
9.38 g/L
Standard Deviation 1.842
|
13.28 g/L
Standard Deviation 3.336
|
|
Measurement of Trough Total IgG Levels
IgG at Screening
|
10.99 g/L
Standard Deviation 2.143
|
11.92 g/L
Standard Deviation 3.352
|
12.17 g/L
Standard Deviation 2.731
|
13.17 g/L
Standard Deviation 3.236
|
SECONDARY outcome
Timeframe: From study start to end, up to 3.5 yearsNumber of participants with serious bacterial infections
Outcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=4 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=4 Participants
Octanorm 16.5%
|
Age >=17 to <=75
n=17 Participants
Octanorm 16.5%
|
|---|---|---|---|---|
|
Number of Participants With Serious Bacterial Infections (SBIs).
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From study start to end, up to 3.5 yearsQuality of Life for patients \>= age 14 assessed using the Short Form 36 Health survey. Likert like scale. The responses given by patients were combined to create 8 SF-36 scores: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health 36 questions that fall into 4 Sub scale scoring ranges: Score 1-5: Where 1 is more favorable than 5 Score 1-3: Where 3 is more favorable than 1 Score 1-5: Where 5 is more favorable than 1 Score 1-6: Where 1 is more favorable than 6 The raw subscale scores are converted into a scale score between 0 to 100 using the Quality Metric Health Outcomes™ Scoring Software 2.0 Scale Title of final scales is: Physical and Mental Health Component Summary Scores Range: Lowest = 0 and highest = 100 where a high score equates to a more favorable health state
Outcome measures
| Measure |
Age >=2 to <6
n=1 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=17 Participants
Octanorm 16.5%
|
Age >=12 to <17
Octanorm 16.5%
|
Age >=17 to <=75
Octanorm 16.5%
|
|---|---|---|---|---|
|
SF-36 Health Survey.
Physical Health Score
|
12.39 score on a scale
|
0.42 score on a scale
Standard Deviation 6.922
|
—
|
—
|
|
SF-36 Health Survey.
Mental Health Score
|
-1.12 score on a scale
|
0.38 score on a scale
Standard Deviation 10.877
|
—
|
—
|
SECONDARY outcome
Timeframe: From study start to end, up to 3.5 yearsQuality of Life for patients ages \<14 years assessed using the CHQ-PF50. Measured values represent change in score from baseline to end of study. Two summary scores were derived: physical and psychosocial. In accord with the scoring manual, computed scores were transformed giving each scale a possible range from 0 to 100, with the exception of change in health, with a possible range from 1 to 5. For all CHQ-PF50 scales, higher scores indicated more positive functioning or better health status.
Outcome measures
| Measure |
Age >=2 to <6
n=2 Participants
Octanorm 16.5%
|
Age >=6 to <12
n=3 Participants
Octanorm 16.5%
|
Age >=12 to <17
n=2 Participants
Octanorm 16.5%
|
Age >=17 to <=75
Octanorm 16.5%
|
|---|---|---|---|---|
|
CHQ-PF50 (Child Health Questionnaire-Parent Form)
Psychosocial Summary
|
-9.07 score on a scale
Standard Deviation 12.361
|
0.50 score on a scale
Standard Deviation 2.679
|
9.92 score on a scale
Standard Deviation 20.860
|
—
|
|
CHQ-PF50 (Child Health Questionnaire-Parent Form)
Physical Summary Score
|
-0.79 score on a scale
Standard Deviation 5.032
|
0.94 score on a scale
Standard Deviation 6.800
|
2.76 score on a scale
Standard Deviation 2.683
|
—
|
Adverse Events
Age >=2 to <6
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Age >=6 to <12
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Age >=12 to <17
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Age >=17 to <=75
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Age >=2 to <6
n=2 participants at risk
Octanorm 16.5%
|
Age >=6 to <12
n=4 participants at risk
Octanorm 16.5%
|
Age >=12 to <17
n=4 participants at risk
Octanorm 16.5%
|
Age >=17 to <=75
n=17 participants at risk
Octanorm 16.5%
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
General disorders
Pyrexia
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Infected bite
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 2 • From study start to end, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 2 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
Other adverse events
| Measure |
Age >=2 to <6
n=2 participants at risk
Octanorm 16.5%
|
Age >=6 to <12
n=4 participants at risk
Octanorm 16.5%
|
Age >=12 to <17
n=4 participants at risk
Octanorm 16.5%
|
Age >=17 to <=75
n=17 participants at risk
Octanorm 16.5%
|
|---|---|---|---|---|
|
Infections and infestations
Diverticulitis
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 2 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Gastroenteritis viral
|
50.0%
1/2 • Number of events 2 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Immune system disorders
Allergic Oedema
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Immune system disorders
Allergy to animal
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 2 • From study start to end, up to 3.5 years
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Psychiatric disorders
Tic
|
50.0%
1/2 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
50.0%
2/4 • Number of events 2 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
11.8%
2/17 • Number of events 3 • From study start to end, up to 3.5 years
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
11.8%
2/17 • Number of events 4 • From study start to end, up to 3.5 years
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
11.8%
2/17 • Number of events 2 • From study start to end, up to 3.5 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Nervous system disorders
Tremor
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Eye disorders
Cataract
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Eye disorders
Corneal infiltrates
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Eye disorders
Eye pruritus
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
50.0%
2/4 • Number of events 2 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 2 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 3 • From study start to end, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
11.8%
2/17 • Number of events 3 • From study start to end, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dypsnoea
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 2 • From study start to end, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypopnoea
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
50.0%
1/2 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 3 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal cyst
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
50.0%
1/2 • Number of events 1 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord disorder
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Gastrointestinal disorders
Gingival disorder
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 3 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Number of events 1 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 3 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
50.0%
1/2 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
11.8%
2/17 • Number of events 2 • From study start to end, up to 3.5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 2 • From study start to end, up to 3.5 years
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 3 • From study start to end, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
11.8%
2/17 • Number of events 5 • From study start to end, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
23.5%
4/17 • Number of events 5 • From study start to end, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
11.8%
2/17 • Number of events 3 • From study start to end, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Interverterbral disc degeneration
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 3 • From study start to end, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 2 • From study start to end, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
11.8%
2/17 • Number of events 4 • From study start to end, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 2 • From study start to end, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 2 • From study start to end, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 3 • From study start to end, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Vertebral osteophyte
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
General disorders
Chills
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 2 • From study start to end, up to 3.5 years
|
|
General disorders
Device dislocation
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
General disorders
Influenza like illness
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
General disorders
Oedema
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
General disorders
Pain
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
General disorders
Pyrexia
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
11.8%
2/17 • Number of events 2 • From study start to end, up to 3.5 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
11.8%
2/17 • Number of events 2 • From study start to end, up to 3.5 years
|
|
Investigations
Blood alcohol increased
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 2 • From study start to end, up to 3.5 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Investigations
Blood lactate dehydrogenase
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Investigations
Haematocrit decreased
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Investigations
International normalised ratio increased
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Investigations
White blood cell count decreased
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
11.8%
2/17 • Number of events 2 • From study start to end, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Exposure to communicable disease
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 2 • From study start to end, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Muscle contusion
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Social circumstances
Postmenopause
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Abscess
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Acute sinusitis
|
50.0%
1/2 • Number of events 1 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Bronchitis
|
50.0%
1/2 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
75.0%
3/4 • Number of events 3 • From study start to end, up to 3.5 years
|
17.6%
3/17 • Number of events 4 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Bronchopulmonary aspergillosis allergic
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Cellulitis
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
11.8%
2/17 • Number of events 2 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Gastritis viral
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Gingivitis
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Infected bite
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 2 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Influenza
|
50.0%
1/2 • Number of events 1 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 2 • From study start to end, up to 3.5 years
|
50.0%
2/4 • Number of events 3 • From study start to end, up to 3.5 years
|
17.6%
3/17 • Number of events 3 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Infusion site infection
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Laryngitis
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Nasopharyngitis
|
50.0%
1/2 • Number of events 1 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
23.5%
4/17 • Number of events 8 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Otitis media
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 2 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Respiratory tract infection viral
|
50.0%
1/2 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Sinusitis
|
50.0%
1/2 • Number of events 1 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
50.0%
2/4 • Number of events 6 • From study start to end, up to 3.5 years
|
47.1%
8/17 • Number of events 29 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Sinusitis fungal
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Tooth infection
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
11.8%
2/17 • Number of events 2 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 2 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 2 • From study start to end, up to 3.5 years
|
0.00%
0/17 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
29.4%
5/17 • Number of events 7 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
25.0%
1/4 • Number of events 1 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
|
Infections and infestations
Wound infection
|
0.00%
0/2 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
0.00%
0/4 • From study start to end, up to 3.5 years
|
5.9%
1/17 • Number of events 1 • From study start to end, up to 3.5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place