Trial Outcomes & Findings for MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients (NCT NCT01959165)
NCT ID: NCT01959165
Last Updated: 2019-07-05
Results Overview
Remission at Week 8 was defined as a total Mayo score 2 points or smaller, and with no individual subscore more than 1 point.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
8 weeks
Results posted on
2019-07-05
Participant Flow
In the protocol part, the number of enrolled participants was 44. This number means 44 participants who were assigned and received the treatment. In fact, 59 participants signed informed consent form. Out of the enrolled, 45 participants were assigned, and 1 out of the 45 participants discontinued the study without receiving any treatment.
Out of the 59 enrolled participants, 14 participapatients were not assigned to any arm. Out of these 14 participants, 13 participants did not meet the eligibility criteria and 1 participants withdrew the informed consent.
Participant milestones
| Measure |
Placebo
placebo double blind phase
|
MEDI7183 21 mg
MEDI7183 21 mg double blind phase
|
MEDI7183 70 mg
MEDI7183 70 mg double blind phase
|
MEDI7183 210 mg
MEDI7183 210 mg double blind phase
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
11
|
12
|
9
|
|
Overall Study
COMPLETED
|
12
|
10
|
12
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo
placebo double blind phase
|
MEDI7183 21 mg
MEDI7183 21 mg double blind phase
|
MEDI7183 70 mg
MEDI7183 70 mg double blind phase
|
MEDI7183 210 mg
MEDI7183 210 mg double blind phase
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
0
|
|
Overall Study
overdose
|
0
|
0
|
0
|
1
|
|
Overall Study
Welfare recipient
|
0
|
1
|
0
|
0
|
Baseline Characteristics
MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients
Baseline characteristics by cohort
| Measure |
Placebo
n=13 Participants
placebo double blind phase
|
MEDI7183 21 mg
n=10 Participants
MEDI7183 21 mg double blind phase
|
MEDI7183 70 mg
n=12 Participants
MEDI7183 70 mg double blind phase
|
MEDI7183 210 mg
n=9 Participants
MEDI7183 210 mg double blind phase
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
38.0 Years
n=93 Participants
|
45.9 Years
n=4 Participants
|
39.8 Years
n=27 Participants
|
33.1 Years
n=483 Participants
|
39.3 Years
n=36 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
29 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
44 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
duration of Ulcerative Colitis
|
5.41 years
n=93 Participants
|
6.75 years
n=4 Participants
|
5.43 years
n=27 Participants
|
3.29 years
n=483 Participants
|
5.28 years
n=36 Participants
|
|
use of 5-aminosalicylates
Number of participants who took the drug
|
11 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
39 Participants
n=36 Participants
|
|
use of oral corticosteroids
Number of paticipants who took the drug
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
|
use of immunomodulators
Number of participants who took the drug
|
7 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
23 Participants
n=36 Participants
|
|
any prior use of anti-TNF-a agents
Number of participants who took the drug
|
8 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
26 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: All randomised participants who received at least one dose of investigational drug during the double-blind phase
Remission at Week 8 was defined as a total Mayo score 2 points or smaller, and with no individual subscore more than 1 point.
Outcome measures
| Measure |
Placebo
n=13 Participants
placebo double blind phase
|
MEDI7183 21 mg
n=10 Participants
MEDI7183 21 mg double blind phase
|
MEDI7183 70 mg
n=12 Participants
MEDI7183 70 mg double blind phase
|
MEDI7183 210 mg
n=9 Participants
MEDI7183 210 mg double blind phase
|
|---|---|---|---|---|
|
Number of Participants With Remission at Week 8
Number of participants with Remission
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: All randomised participants who received at least one dose of investigational drug during the double-blind phase
Response at Week 8 was assessed by total Mayo score. Response was defined as decrease 3 points or more and 30 percents in total Mayo score compared to baseline, and with an accompanying decrease in the subscore for rectal bleeding of 1 point or more, or with an absolute subscore for rectal bleeding of 0 or 1.
Outcome measures
| Measure |
Placebo
n=13 Participants
placebo double blind phase
|
MEDI7183 21 mg
n=10 Participants
MEDI7183 21 mg double blind phase
|
MEDI7183 70 mg
n=12 Participants
MEDI7183 70 mg double blind phase
|
MEDI7183 210 mg
n=9 Participants
MEDI7183 210 mg double blind phase
|
|---|---|---|---|---|
|
Number of Participants With Response at Week 8
Number of participants with Response
|
7 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: All randomised participants who received at least one dose of investigational drug during the double-blind phase
Mucosal healing was defined as an absolute Mayo subscore for rectosigmoidoscopy of 0 or 1.
Outcome measures
| Measure |
Placebo
n=13 Participants
placebo double blind phase
|
MEDI7183 21 mg
n=10 Participants
MEDI7183 21 mg double blind phase
|
MEDI7183 70 mg
n=12 Participants
MEDI7183 70 mg double blind phase
|
MEDI7183 210 mg
n=9 Participants
MEDI7183 210 mg double blind phase
|
|---|---|---|---|---|
|
Number of Participants With Mucosal Healing at Week 8
Number of participants with Mucosal healing
|
4 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All randomised participants who received at least one dose of investigational drug during the double-blind phase
Response at Week 12 was assessed by Partial Mayo Score. Response was defined as reduction by 2 or more points and 25% in Partial Mayo Score compared to baseline.
Outcome measures
| Measure |
Placebo
n=13 Participants
placebo double blind phase
|
MEDI7183 21 mg
n=10 Participants
MEDI7183 21 mg double blind phase
|
MEDI7183 70 mg
n=12 Participants
MEDI7183 70 mg double blind phase
|
MEDI7183 210 mg
n=9 Participants
MEDI7183 210 mg double blind phase
|
|---|---|---|---|---|
|
Number of Participants With Response at Week 12
Number of participants with Response
|
6 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
MEDI7183 21 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
MEDI7183 70 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
MEDI7183 210 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=13 participants at risk
placebo double blind period
|
MEDI7183 21 mg
n=10 participants at risk
MEDI7183 21 mg double blind phase
|
MEDI7183 70 mg
n=12 participants at risk
MEDI7183 70 mg double blind period
|
MEDI7183 210 mg
n=9 participants at risk
MEDI7183 210 mg double blind period
|
|---|---|---|---|---|
|
Gastrointestinal disorders
colitis ulcerative
|
0.00%
0/13 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
10.0%
1/10 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/12 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/9 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Nervous system disorders
cerebral infarction
|
0.00%
0/13 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/10 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/12 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
11.1%
1/9 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
Other adverse events
| Measure |
Placebo
n=13 participants at risk
placebo double blind period
|
MEDI7183 21 mg
n=10 participants at risk
MEDI7183 21 mg double blind phase
|
MEDI7183 70 mg
n=12 participants at risk
MEDI7183 70 mg double blind period
|
MEDI7183 210 mg
n=9 participants at risk
MEDI7183 210 mg double blind period
|
|---|---|---|---|---|
|
Infections and infestations
nasopharyngitis
|
23.1%
3/13 • Number of events 3 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
20.0%
2/10 • Number of events 2 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
25.0%
3/12 • Number of events 3 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
22.2%
2/9 • Number of events 2 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Gastrointestinal disorders
colitis ulcerative
|
7.7%
1/13 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/10 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/12 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/9 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Gastrointestinal disorders
proctalgia
|
0.00%
0/13 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/10 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/12 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
11.1%
1/9 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/13 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
10.0%
1/10 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/12 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/9 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Respiratory, thoracic and mediastinal disorders
asthma
|
0.00%
0/13 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
10.0%
1/10 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/12 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/9 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
General disorders
malaise
|
7.7%
1/13 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/10 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/12 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
11.1%
1/9 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Infections and infestations
enterocolitis viral
|
7.7%
1/13 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/10 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
8.3%
1/12 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/9 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Skin and subcutaneous tissue disorders
xeroderma
|
0.00%
0/13 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
10.0%
1/10 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/12 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/9 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Nervous system disorders
headache
|
0.00%
0/13 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
10.0%
1/10 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/12 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
11.1%
1/9 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Nervous system disorders
dizziness
|
0.00%
0/13 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/10 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
8.3%
1/12 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/9 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Blood and lymphatic system disorders
iron deficiency anaemia
|
7.7%
1/13 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/10 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/12 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/9 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Injury, poisoning and procedural complications
contusion
|
7.7%
1/13 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/10 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/12 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/9 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Infections and infestations
gingivitis
|
7.7%
1/13 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/10 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/12 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/9 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
General disorders
injection site swelling
|
7.7%
1/13 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/10 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/12 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/9 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Investigations
blood creatine phosphokinase increased
|
0.00%
0/13 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/10 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
8.3%
1/12 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/9 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Investigations
weight decreased
|
7.7%
1/13 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/10 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/12 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/9 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Investigations
white blood cell count decreased
|
0.00%
0/13 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
10.0%
1/10 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/12 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/9 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhoea
|
7.7%
1/13 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/10 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/12 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/9 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Skin and subcutaneous tissue disorders
dermatitis allergic
|
0.00%
0/13 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/10 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/12 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
11.1%
1/9 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Skin and subcutaneous tissue disorders
skin swelling
|
0.00%
0/13 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
10.0%
1/10 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/12 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/9 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Blood and lymphatic system disorders
lymph node pain
|
0.00%
0/13 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
10.0%
1/10 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/12 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/9 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Eye disorders
cataract
|
0.00%
0/13 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
10.0%
1/10 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/12 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/9 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Eye disorders
dry eye
|
7.7%
1/13 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/10 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/12 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/9 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Eye disorders
visual impairment
|
0.00%
0/13 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
10.0%
1/10 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/12 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/9 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Injury, poisoning and procedural complications
tooth fracture
|
7.7%
1/13 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/10 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/12 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/9 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Musculoskeletal and connective tissue disorders
flank pain
|
0.00%
0/13 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/10 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
8.3%
1/12 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/9 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Musculoskeletal and connective tissue disorders
temporomandibular joint syndrome
|
7.7%
1/13 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/10 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/12 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/9 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
|
Vascular disorders
hypotension
|
7.7%
1/13 • Number of events 1 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/10 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/12 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
0.00%
0/9 • 12 weeks for DB period.
AEs were collected after dosing. SAEs were collected after consent date.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60