Trial Outcomes & Findings for A Study to Evaluate the Efficacy, Safety and Tolerability of MIV-711 in Osteoarthritis Patients (NCT NCT02705625)
NCT ID: NCT02705625
Last Updated: 2019-06-17
Results Overview
Change from Visit 2 (Baseline) to Visit 8 (Week 26) in NRS average target knee pain score. NRS (Numeric rating scale) ranges from 0 indicating -"no pain", to 10 indicating - "pain as bad as it could be".
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
244 participants
Primary outcome timeframe
baseline and 26 weeks
Results posted on
2019-06-17
Participant Flow
Participant milestones
| Measure |
MIV-711:100 mg
MIV-711 100 mg administered orally once daily for a total of 26 weeks
|
MIV-711:200 mg
MIV-711 200 mg administered orally once daily for a total of 26 weeks
|
Placebo
Placebo manufactured to mimic MIV-711 capsule administered orally once daily for a total of 26 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
82
|
82
|
80
|
|
Overall Study
COMPLETED
|
74
|
72
|
69
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
11
|
Reasons for withdrawal
| Measure |
MIV-711:100 mg
MIV-711 100 mg administered orally once daily for a total of 26 weeks
|
MIV-711:200 mg
MIV-711 200 mg administered orally once daily for a total of 26 weeks
|
Placebo
Placebo manufactured to mimic MIV-711 capsule administered orally once daily for a total of 26 weeks
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
6
|
5
|
2
|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
5
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Non-compliance
|
0
|
1
|
1
|
|
Overall Study
Overdosing
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Efficacy, Safety and Tolerability of MIV-711 in Osteoarthritis Patients
Baseline characteristics by cohort
| Measure |
MIV-711:100 mg
n=82 Participants
MIV-711 100 mg administered orally once daily for a total of 26 weeks
|
MIV-711:200 mg
n=81 Participants
MIV-711 200 mg administered orally once daily for a total of 26 weeks
|
Placebo
n=77 Participants
Placebo manufactured to mimic MIV-711 capsule administered orally once daily for a total of 26 weeks
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 6.58 • n=5 Participants
|
62.0 years
STANDARD_DEVIATION 7.33 • n=7 Participants
|
62.3 years
STANDARD_DEVIATION 6.59 • n=5 Participants
|
61.8 years
STANDARD_DEVIATION 6.83 • n=4 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
184 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
56 Participants
n=4 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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
238 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (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
|
|
Region of Enrollment
Romania
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Moldova
|
26 participants
n=5 Participants
|
29 participants
n=7 Participants
|
36 participants
n=5 Participants
|
91 participants
n=4 Participants
|
|
Region of Enrollment
Georgia
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
7 participants
n=5 Participants
|
33 participants
n=4 Participants
|
|
Region of Enrollment
Bulgaria
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
9 participants
n=5 Participants
|
37 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
26 participants
n=5 Participants
|
22 participants
n=7 Participants
|
21 participants
n=5 Participants
|
69 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and 26 weeksPopulation: As there were discontinuations in the study, not all patients in the mITT population had an assessment at week 26. The analysis population is therefore equal to the number of patients completing the study for this outcome measure.
Change from Visit 2 (Baseline) to Visit 8 (Week 26) in NRS average target knee pain score. NRS (Numeric rating scale) ranges from 0 indicating -"no pain", to 10 indicating - "pain as bad as it could be".
Outcome measures
| Measure |
MIV-711:100 mg
n=74 Participants
MIV-711 100 mg administered orally once daily for a total of 26 weeks
|
MIV-711:200 mg
n=72 Participants
MIV-711 200 mg administered orally once daily for a total of 26 weeks
|
Placebo
n=69 Participants
Placebo, manufactured to mimic MIV-711 capsule, administered orally once daily for a total of 26 weeks
|
|---|---|---|---|
|
Numeric Rating Scale (NRS) Average Target Knee Pain Score at Week 26
|
-1.7 score
Standard Deviation 2.01
|
-1.5 score
Standard Deviation 1.95
|
-1.3 score
Standard Deviation 2.15
|
SECONDARY outcome
Timeframe: baseline and 26 weeksPopulation: As there were discontinuations in the study, not all patients in the mITT population had an MRI assessment at week 26. In addition, there were patients with non valid MRIs. The analysis population is therefore smaller than the Participant Flow.
Change from Visit 2 (Baseline) to Visit 8 (Week 26) in MRI (Magnetic Resonance Imaging;) bone area of the target knee in mm\^2.
Outcome measures
| Measure |
MIV-711:100 mg
n=69 Participants
MIV-711 100 mg administered orally once daily for a total of 26 weeks
|
MIV-711:200 mg
n=69 Participants
MIV-711 200 mg administered orally once daily for a total of 26 weeks
|
Placebo
n=66 Participants
Placebo, manufactured to mimic MIV-711 capsule, administered orally once daily for a total of 26 weeks
|
|---|---|---|---|
|
Magnetic Resonance Imaging (MRI) Bone Area of the Target Knee at Week 26
|
8.1290 mm^2
Standard Deviation 31.10846
|
8.2142 mm^2
Standard Deviation 29.39941
|
23.2234 mm^2
Standard Deviation 32.68365
|
SECONDARY outcome
Timeframe: baseline and 26 weeksPopulation: As there were discontinuations in the study, not all patients in the mITT population had an MRI assessment at week 26. In addition, there were patients with non valid MRIs. The analysis population is therefore smaller than the Participant Flow.
Change from Visit 2 (baseline) to Visit 8 (week 26) in MRI cartilage thickness in the Central Medial Femur Region of the target knee in mm.
Outcome measures
| Measure |
MIV-711:100 mg
n=69 Participants
MIV-711 100 mg administered orally once daily for a total of 26 weeks
|
MIV-711:200 mg
n=69 Participants
MIV-711 200 mg administered orally once daily for a total of 26 weeks
|
Placebo
n=66 Participants
Placebo, manufactured to mimic MIV-711 capsule, administered orally once daily for a total of 26 weeks
|
|---|---|---|---|
|
Magnetic Resonance Imaging (MRI) of Cartilage Thickness (Femur) at Week 26
|
0.0077 mm
Standard Deviation 0.19258
|
-0.0171 mm
Standard Deviation 0.24113
|
-0.0658 mm
Standard Deviation 0.21904
|
SECONDARY outcome
Timeframe: baseline and 26 weeksPopulation: As there were discontinuations in the study, not all patients in the mITT population had an assessment at week 26. The analysis population is therefore equal to the number of patients completing the study for this outcome measure.
Change from Visit 2 (Baseline) to Visit 8 (Week 26) in normalised WOMAC pain score. The WOMAC responses are scored using an 11-point NRS where 0=none and 10=extreme. There are 5 questions in the WOMAC pain scale which is summed up for the total WOMAC score, leading to a range of 0 to 50. The total WOMAC pain score has been standardised to a scale with a range from 0 to 100 (where 100 is extreme pain): \- Normalised WOMAC pain score = Total WOMAC pain score multiplicated with 2.
Outcome measures
| Measure |
MIV-711:100 mg
n=74 Participants
MIV-711 100 mg administered orally once daily for a total of 26 weeks
|
MIV-711:200 mg
n=72 Participants
MIV-711 200 mg administered orally once daily for a total of 26 weeks
|
Placebo
n=69 Participants
Placebo, manufactured to mimic MIV-711 capsule, administered orally once daily for a total of 26 weeks
|
|---|---|---|---|
|
Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain Score
|
-16.6 score
Standard Deviation 19.35
|
-13.0 score
Standard Deviation 18.6
|
-9.8 score
Standard Deviation 21.89
|
SECONDARY outcome
Timeframe: baseline and 26 weeksPopulation: As there were discontinuations in the study, not all patients in the mITT population had an assessment at week 26. The analysis population is therefore equal to the number of patients completing the study for this outcome measure.
Change from Visit 2 (Baseline) to Visit 8 (Week 26) in normalised WOMAC difficulty score. The WOMAC responses are scored using an 11-point NRS where 0=none and 10=extreme. There are 17 questions in the WOMAC difficulty scale which is summed up for the total WOMAC difficulty score, leading to a range of 0 to 170. The total WOMAC difficulty score has been standardised to a scale with a range from 0 to 100 (where 100 is extreme pain): \- Normalised WOMAC difficulty score = Total WOMAC difficulty score divided with 1.7
Outcome measures
| Measure |
MIV-711:100 mg
n=74 Participants
MIV-711 100 mg administered orally once daily for a total of 26 weeks
|
MIV-711:200 mg
n=72 Participants
MIV-711 200 mg administered orally once daily for a total of 26 weeks
|
Placebo
n=69 Participants
Placebo, manufactured to mimic MIV-711 capsule, administered orally once daily for a total of 26 weeks
|
|---|---|---|---|
|
Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Difficulty Score
|
-16.39 score
Standard Deviation 20.937
|
-13.95 score
Standard Deviation 20.668
|
-9.9 score
Standard Deviation 21.862
|
SECONDARY outcome
Timeframe: baseline and 26 weeksPopulation: As there were discontinuations in the study, not all patients in the mITT population had an assessment at week 26. The analysis population is therefore equal to the number of patients completing the study for this outcome measure.
Change from Visit 2 (Baseline) to Visit 8 (Week 26) in normalised WOMAC stiffness score. The WOMAC responses are scored using an 11-point NRS where 0=none and 10=extreme. There are 2 questions in the WOMAC stiffness scale which is summed up for the total WOMAC stiffness score, leading to a range of 0 to 20. The total WOMAC stiffness score has been standardised to a scale with a range from 0 to 100 (where 100 is extreme pain): \- Normalised WOMAC stiffness score = Total WOMAC stiffness score multiplicated with 5
Outcome measures
| Measure |
MIV-711:100 mg
n=74 Participants
MIV-711 100 mg administered orally once daily for a total of 26 weeks
|
MIV-711:200 mg
n=72 Participants
MIV-711 200 mg administered orally once daily for a total of 26 weeks
|
Placebo
n=69 Participants
Placebo, manufactured to mimic MIV-711 capsule, administered orally once daily for a total of 26 weeks
|
|---|---|---|---|
|
Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score
|
-17 score
Standard Deviation 24.69
|
-14.5 score
Standard Deviation 22.71
|
-9.8 score
Standard Deviation 24.71
|
SECONDARY outcome
Timeframe: baseline and 26 weeksPopulation: As there were discontinuations in the study, not all patients in the mITT population had an assessment at week 26. In addition, there was one missing sample for serum CTX-I. The analysis population is therefore smaller than in the Participant Flow.
Change from Visit 2 (baseline) to Visit 8 (week 26) in serum CTX-I, a biomarker for bone resorption.
Outcome measures
| Measure |
MIV-711:100 mg
n=74 Participants
MIV-711 100 mg administered orally once daily for a total of 26 weeks
|
MIV-711:200 mg
n=71 Participants
MIV-711 200 mg administered orally once daily for a total of 26 weeks
|
Placebo
n=69 Participants
Placebo, manufactured to mimic MIV-711 capsule, administered orally once daily for a total of 26 weeks
|
|---|---|---|---|
|
Serum C-terminal Telopeptide of Collagen Type I (CTX-I) at Week 26
|
-0.1209 ug/L
Standard Deviation 0.16733
|
-0.2575 ug/L
Standard Deviation 0.19931
|
0.0000 ug/L
Standard Deviation 0.16165
|
SECONDARY outcome
Timeframe: baseline and 26 weeksPopulation: As there were discontinuations in the study, not all patients in the mITT population had an assessment at week 26. In addition, there was two missing samples for urine CTX-II. The analysis population is therefore smaller than in the Participant Flow.
Change from Visit 2 (baseline) to Visit 8 (week 26) in creatinine corrected urine CTX-II, a biomarker for cartilage degradation.
Outcome measures
| Measure |
MIV-711:100 mg
n=73 Participants
MIV-711 100 mg administered orally once daily for a total of 26 weeks
|
MIV-711:200 mg
n=72 Participants
MIV-711 200 mg administered orally once daily for a total of 26 weeks
|
Placebo
n=68 Participants
Placebo, manufactured to mimic MIV-711 capsule, administered orally once daily for a total of 26 weeks
|
|---|---|---|---|
|
Creatinine Corrected Urine C-terminal Telopeptide of Collagen Type II (CTX-II) at Week 26
|
-138.0 ng/mmol
Standard Deviation 198.68
|
-242.5 ng/mmol
Standard Deviation 266.56
|
28.4 ng/mmol
Standard Deviation 225.69
|
Adverse Events
MIV-711:100 mg
Serious events: 3 serious events
Other events: 33 other events
Deaths: 0 deaths
MIV-711:200 mg
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 33 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
MIV-711:100 mg
n=82 participants at risk
MIV-711 100 mg administered orally once daily for a total of 26 weeks
|
MIV-711:200 mg
n=82 participants at risk
MIV-711 200 mg administered orally once daily for a total of 26 weeks
|
Placebo
n=80 participants at risk
Placebo, manufactured to mimic MIV-711 capsule, administered orally once daily for a total of 26 weeks
|
|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
0.00%
0/82 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
0.00%
0/80 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/82 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
0.00%
0/82 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
|
Cardiac disorders
Prinzmetal angina
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
0.00%
0/82 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
0.00%
0/80 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/82 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
0.00%
0/80 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
|
Infections and infestations
Pyelonephritis chronic
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
0.00%
0/82 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
0.00%
0/80 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
|
Injury, poisoning and procedural complications
Compression fracture
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
0.00%
0/82 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
0.00%
0/80 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
|
Injury, poisoning and procedural complications
Contussion
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
0.00%
0/82 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
0.00%
0/80 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/82 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
0.00%
0/80 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
|
Vascular disorders
Haematoma
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
0.00%
0/82 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
0.00%
0/80 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
Other adverse events
| Measure |
MIV-711:100 mg
n=82 participants at risk
MIV-711 100 mg administered orally once daily for a total of 26 weeks
|
MIV-711:200 mg
n=82 participants at risk
MIV-711 200 mg administered orally once daily for a total of 26 weeks
|
Placebo
n=80 participants at risk
Placebo, manufactured to mimic MIV-711 capsule, administered orally once daily for a total of 26 weeks
|
|---|---|---|---|
|
Vascular disorders
Hypertension
|
0.00%
0/82 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
5.0%
4/80 • Number of events 4 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
0.00%
0/82 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
5.0%
4/80 • Number of events 4 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
|
Nervous system disorders
Headache
|
6.1%
5/82 • Number of events 6 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
6.1%
5/82 • Number of events 5 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
7.5%
6/80 • Number of events 8 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
8.5%
7/82 • Number of events 7 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
7.3%
6/82 • Number of events 6 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
8.8%
7/80 • Number of events 8 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
7.3%
6/82 • Number of events 6 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
3.8%
3/80 • Number of events 3 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
5/82 • Number of events 5 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
2.4%
2/82 • Number of events 2 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
2.5%
2/80 • Number of events 4 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.3%
6/82 • Number of events 7 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
0.00%
0/82 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
|
Infections and infestations
Nasopharyngitis
|
9.8%
8/82 • Number of events 8 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
8.5%
7/82 • Number of events 9 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
7.5%
6/80 • Number of events 6 • Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place