Trial Outcomes & Findings for Single Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of BDM-2 in Healthy Male Subjects. (NCT NCT03634085)
NCT ID: NCT03634085
Last Updated: 2020-06-17
Results Overview
All AEs, including clinical laboratory, vitals signs, body temperature, respiratory rate, physical examinations and ECGs will be analyzed in all subjects receiving BDM-2.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
up to 4 months
Results posted on
2020-06-17
Participant Flow
Participant milestones
| Measure |
Cohort A
Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort A of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.
The last session for the subjects in Cohort A will be under fed conditions where the same treatment allocation as in the session of the selected dose (administered under fasted conditions) will be used.
BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration.
|
Cohort B
Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort B of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.
BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
Period 1
|
8
|
8
|
|
Overall Study
Period 2
|
8
|
8
|
|
Overall Study
Period 3
|
8
|
8
|
|
Overall Study
Period 4
|
8
|
0
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Cohort A
Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort A of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.
The last session for the subjects in Cohort A will be under fed conditions where the same treatment allocation as in the session of the selected dose (administered under fasted conditions) will be used.
BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration.
|
Cohort B
Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort B of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.
BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Single Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of BDM-2 in Healthy Male Subjects.
Baseline characteristics by cohort
| Measure |
Cohort A
n=8 Participants
Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort A of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.
The last session for the subjects in Cohort A will be under fed conditions where the same treatment allocation as in the session of the selected dose (administered under fasted conditions) will be used.
BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration.
|
Cohort B
n=8 Participants
Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort B of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.
BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
32.0 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
36.6 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
34.3 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 4 monthsPopulation: The same 8 subjects attended Period 1-4 for Cohort A and 8 other subjects attended Period 1-3 for Cohort B, therefore all randomized subjects who received at least 1 dose of trial medication are displayed in this section. For both cohorts this are 8 subjects, so all AEs per cohort are based on 8 subjects.
All AEs, including clinical laboratory, vitals signs, body temperature, respiratory rate, physical examinations and ECGs will be analyzed in all subjects receiving BDM-2.
Outcome measures
| Measure |
Cohort A
n=8 Participants
Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort A of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.
The last session for the subjects in Cohort A will be under fed conditions where the same treatment allocation as in the session of the selected dose (administered under fasted conditions) will be used.
BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration.
|
Cohort B
n=8 Participants
Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort B of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.
BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration.
|
|---|---|---|
|
Number of Treatment Related Adverse Event, Including Abnormal Laboratory Events
450mg CohA - 900mg fast CohB
|
4 participants
|
9 participants
|
|
Number of Treatment Related Adverse Event, Including Abnormal Laboratory Events
placebo
|
1 participants
|
3 participants
|
|
Number of Treatment Related Adverse Event, Including Abnormal Laboratory Events
50 mg CohA - 150mg Coh B
|
2 participants
|
4 participants
|
|
Number of Treatment Related Adverse Event, Including Abnormal Laboratory Events
1800mg CohA - 900mg fed CohB
|
4 participants
|
4 participants
|
|
Number of Treatment Related Adverse Event, Including Abnormal Laboratory Events
3100mg Coh A
|
3 participants
|
—
|
Adverse Events
Cohort A-placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort B-placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort A-50mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort B-150mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort A-450mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort B-900mg Fasted
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort A-1800mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort B-900mg Fed
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort A-3100mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort A-placebo
n=8 participants at risk
Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort A of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.
The last session for the subjects in Cohort A will be under fed conditions where the same treatment allocation as in the session of the selected dose (administered under fasted conditions) will be used.
BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration.
|
Cohort B-placebo
n=5 participants at risk
Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort B of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.
BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration.
|
Cohort A-50mg
n=5 participants at risk
Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort A of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.
The last session for the subjects in Cohort A will be under fed conditions where the same treatment allocation as in the session of the selected dose (administered under fasted conditions) will be used.
BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration.
|
Cohort B-150mg
n=6 participants at risk
Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort B of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.
BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration.
|
Cohort A-450mg
n=6 participants at risk
Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort A of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.
The last session for the subjects in Cohort A will be under fed conditions where the same treatment allocation as in the session of the selected dose (administered under fasted conditions) will be used.
BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration.
|
Cohort B-900mg Fasted
n=6 participants at risk
Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort B of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.
BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration.
|
Cohort A-1800mg
n=5 participants at risk
Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort A of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.
The last session for the subjects in Cohort A will be under fed conditions where the same treatment allocation as in the session of the selected dose (administered under fasted conditions) will be used.
BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration.
|
Cohort B-900mg Fed
n=5 participants at risk
Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort B of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.
BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration.
|
Cohort A-3100mg
n=5 participants at risk
Ascending doses of BDM-2 in Bottle (50 mg - 3600 mg); oral suspension or placebo will be orally administered and will be investigated, alternately dosed in Cohort A of 8 healthy male subjects under fasted conditions. For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo.
The last session for the subjects in Cohort A will be under fed conditions where the same treatment allocation as in the session of the selected dose (administered under fasted conditions) will be used.
BDM-2 in Bottle (50 mg - 3600 mg); oral suspension: BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
diarrhoea
|
0.00%
0/8 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
33.3%
2/6 • Number of events 2 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
40.0%
2/5 • Number of events 2 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
20.0%
1/5 • Number of events 1 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
60.0%
3/5 • Number of events 3 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
33.3%
2/6 • Number of events 2 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
|
Respiratory, thoracic and mediastinal disorders
Nausea
|
0.00%
0/8 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
16.7%
1/6 • Number of events 1 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
16.7%
1/6 • Number of events 1 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
0.00%
0/8 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
20.0%
1/5 • Number of events 1 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
16.7%
1/6 • Number of events 1 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
16.7%
1/6 • Number of events 1 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
40.0%
2/5 • Number of events 2 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
|
Respiratory, thoracic and mediastinal disorders
dry throat
|
0.00%
0/8 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
20.0%
1/5 • Number of events 1 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
|
Nervous system disorders
dizziness
|
0.00%
0/8 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
20.0%
1/5 • Number of events 1 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
20.0%
1/5 • Number of events 1 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
20.0%
1/5 • Number of events 1 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
|
Nervous system disorders
headache
|
0.00%
0/8 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
33.3%
2/6 • Number of events 2 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
16.7%
1/6 • Number of events 1 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
|
Nervous system disorders
somnolence
|
0.00%
0/8 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
16.7%
1/6 • Number of events 1 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
|
General disorders
feeling abnormal
|
0.00%
0/8 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
16.7%
1/6 • Number of events 1 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
|
Nervous system disorders
Dysgeusia
|
12.5%
1/8 • Number of events 1 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
20.0%
1/5 • Number of events 1 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
20.0%
1/5 • Number of events 1 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
|
Gastrointestinal disorders
Abdomonal mass
|
0.00%
0/8 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
16.7%
1/6 • Number of events 1 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
|
Nervous system disorders
loss of contiousness
|
0.00%
0/8 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
16.7%
1/6 • Number of events 1 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
0.00%
0/8 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
16.7%
1/6 • Number of events 1 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
|
Injury, poisoning and procedural complications
arthropod bite
|
0.00%
0/8 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
20.0%
1/5 • Number of events 1 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
|
Injury, poisoning and procedural complications
skin abrasion
|
0.00%
0/8 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/6 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
20.0%
1/5 • Number of events 1 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
0.00%
0/5 • 4 months
Each cohort has 8 subjects. Cohort A subjects attended Period 1-4 and Cohort B subjects attended Period 1-3. Arm A has 4 interventions in 8 subjects (6 on active, 2 on placebo) and Arm B has 3 intreventions in 8 subjects (6 on active and 2 on placebo). The affected subjects in Cohort A cannot be more than 8 subjects and the same accounts for Cohort B. There were a couple of dropouts, therefore the amount of affected subjects differs in placebos and other arms between the interventions.
|
Additional Information
Simone van Broekhoven / Clinical Trial Manager
Venn Life Sciences
Phone: +310765480625
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The PI shall have no right to publish the Research Output, without the Customer's prior written consent. The Parties make their best efforts to reach an agreement on the issue of conditions of the publication of the Reseach Output. In case of repeated disagreement, Customer shall be the sole Party to decide in its capacity of Sponsor under what conditions and release period the Research Output should be published.
- Publication restrictions are in place
Restriction type: OTHER