Trial Outcomes & Findings for Oral Testosterone for the Treatment of Hypogonadism (NCT NCT01717768)
NCT ID: NCT01717768
Last Updated: 2015-12-15
Results Overview
Percentage of subjects achieving a 24-hour average total serum testosterone concentration (Cavg,0-24h) in the range of 300 to 1050 ng/dL after 15 days of treatment with TSX-002. PK samples taken at 0 ,2 ,4, 5 ,6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8 ,12, 13, 14, 15, 16, 17, 18, 20, 24 hours post-dose after 15 days of treatment for Part 4.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
130 participants
Primary outcome timeframe
15 days
Results posted on
2015-12-15
Participant Flow
130 subjects were recruited at 1 center in the US from October 2012 to May 2014. The study was designed with 4 parts, including 9 different dosages of the investigational drug.
Participant milestones
| Measure |
Part 1: 120 mg BID
Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 1: 240 mg BID
Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 2: 120 mg BID
Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 3: A-B-C 120 mg QD
Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 3: B-C-A 120 mg QD
Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
|
Part 3: C-A-B 120 mg QD
Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
|
Part 4 Cohort 1: 60 mg BID
Oral TSX-002 60 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 1: 60 mg TID
Oral TSX-002 60 mg TID for 15 days
TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 2: 90 mg BID
Oral TSX-002 90 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 2: 90 mg TID
Oral TSX-002 90 mg TID for 15 days
|
Part 4 Cohort 3: 180 mg QD
Oral TSX-002 180 mg once daily (QD) for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 4: 120 mg BID
Oral TSX-002 120 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 (Duration of 15 Days)
STARTED
|
17
|
17
|
0
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0
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0
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0
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0
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0
|
0
|
0
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0
|
0
|
|
Part 1 (Duration of 15 Days)
COMPLETED
|
17
|
16
|
0
|
0
|
0
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0
|
0
|
0
|
0
|
0
|
0
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0
|
|
Part 1 (Duration of 15 Days)
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
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0
|
0
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0
|
|
Part 2 (Duration of 15 Days)
STARTED
|
0
|
0
|
17
|
0
|
0
|
0
|
0
|
0
|
0
|
0
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0
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0
|
|
Part 2 (Duration of 15 Days)
COMPLETED
|
0
|
0
|
17
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 (Duration of 15 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3 - Treatment 1 (Duration of 1 Day)
STARTED
|
0
|
0
|
0
|
4
|
5
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3 - Treatment 1 (Duration of 1 Day)
COMPLETED
|
0
|
0
|
0
|
4
|
5
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3 - Treatment 1 (Duration of 1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3 - Treatment 2 (Duration of 1 Day)
STARTED
|
0
|
0
|
0
|
4
|
5
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3 - Treatment 2 (Duration of 1 Day)
COMPLETED
|
0
|
0
|
0
|
4
|
5
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3 - Treatment 2 (Duration of 1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3 - Treatment 3 (Duration of 1 Day)
STARTED
|
0
|
0
|
0
|
4
|
5
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3 - Treatment 3 (Duration of 1 Day)
COMPLETED
|
0
|
0
|
0
|
4
|
5
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3 - Treatment 3 (Duration of 1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 4-Treatment 1 (Duration of 15 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
17
|
0
|
16
|
0
|
16
|
16
|
|
Part 4-Treatment 1 (Duration of 15 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
17
|
0
|
16
|
0
|
16
|
15
|
|
Part 4-Treatment 1 (Duration of 15 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part 4-Treatment 2 (Duration of 15 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
17
|
0
|
16
|
0
|
0
|
|
Part 4-Treatment 2 (Duration of 15 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
15
|
0
|
15
|
0
|
0
|
|
Part 4-Treatment 2 (Duration of 15 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1: 120 mg BID
Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 1: 240 mg BID
Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 2: 120 mg BID
Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 3: A-B-C 120 mg QD
Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 3: B-C-A 120 mg QD
Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
|
Part 3: C-A-B 120 mg QD
Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
|
Part 4 Cohort 1: 60 mg BID
Oral TSX-002 60 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 1: 60 mg TID
Oral TSX-002 60 mg TID for 15 days
TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 2: 90 mg BID
Oral TSX-002 90 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 2: 90 mg TID
Oral TSX-002 90 mg TID for 15 days
|
Part 4 Cohort 3: 180 mg QD
Oral TSX-002 180 mg once daily (QD) for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 4: 120 mg BID
Oral TSX-002 120 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 (Duration of 15 Days)
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 4-Treatment 1 (Duration of 15 Days)
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part 4-Treatment 2 (Duration of 15 Days)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Part 4-Treatment 2 (Duration of 15 Days)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Oral Testosterone for the Treatment of Hypogonadism
Baseline characteristics by cohort
| Measure |
Part 1: 120 mg BID
n=17 Participants
Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 1: 240 mg BID
n=17 Participants
Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 2: 120 mg BID
n=17 Participants
Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 3: A-B-C 120 mg QD
n=4 Participants
Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 3: B-C-A 120 mg QD
n=5 Participants
Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 3: C-A-B 120 mg QD
n=5 Participants
Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 1: 60 mg BID/ 60 mg TID
n=17 Participants
Oral TSX-002 60 mg BID for 15 days then 60 mg TID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 2: 90 mg BID/ 90 mg TID
n=16 Participants
Oral TSX-002 90 mg BID for 15 days then 90 mg TID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 3: 180 mg QD
n=16 Participants
Oral TSX-002 180 mg once daily (QD) for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 4: 120 mg BID
n=16 Participants
Oral TSX-002 120 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
65-74 years
|
3 participants
n=93 Participants
|
2 participants
n=4 Participants
|
3 participants
n=27 Participants
|
1 participants
n=483 Participants
|
0 participants
n=36 Participants
|
1 participants
n=10 Participants
|
3 participants
n=115 Participants
|
4 participants
n=40 Participants
|
0 participants
n=8 Participants
|
2 participants
n=62 Participants
|
19 participants
n=95 Participants
|
|
Age, Customized
75 years or older
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
1 participants
n=483 Participants
|
0 participants
n=36 Participants
|
0 participants
n=10 Participants
|
1 participants
n=115 Participants
|
0 participants
n=40 Participants
|
0 participants
n=8 Participants
|
0 participants
n=62 Participants
|
4 participants
n=95 Participants
|
|
Age, Customized
<50 years
|
2 participants
n=93 Participants
|
4 participants
n=4 Participants
|
8 participants
n=27 Participants
|
1 participants
n=483 Participants
|
1 participants
n=36 Participants
|
0 participants
n=10 Participants
|
4 participants
n=115 Participants
|
4 participants
n=40 Participants
|
9 participants
n=8 Participants
|
5 participants
n=62 Participants
|
38 participants
n=95 Participants
|
|
Age, Customized
50-64 years
|
11 participants
n=93 Participants
|
11 participants
n=4 Participants
|
5 participants
n=27 Participants
|
1 participants
n=483 Participants
|
4 participants
n=36 Participants
|
4 participants
n=10 Participants
|
9 participants
n=115 Participants
|
8 participants
n=40 Participants
|
7 participants
n=8 Participants
|
9 participants
n=62 Participants
|
69 participants
n=95 Participants
|
|
Sex/Gender, Customized
Male
|
17 participants
n=93 Participants
|
17 participants
n=4 Participants
|
17 participants
n=27 Participants
|
4 participants
n=483 Participants
|
5 participants
n=36 Participants
|
5 participants
n=10 Participants
|
17 participants
n=115 Participants
|
16 participants
n=40 Participants
|
16 participants
n=8 Participants
|
16 participants
n=62 Participants
|
130 participants
n=95 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
2 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
2 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
2 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
27 Participants
n=95 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
12 Participants
n=40 Participants
|
13 Participants
n=8 Participants
|
12 Participants
n=62 Participants
|
96 Participants
n=95 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=93 Participants
|
17 participants
n=4 Participants
|
17 participants
n=27 Participants
|
4 participants
n=483 Participants
|
5 participants
n=36 Participants
|
5 participants
n=10 Participants
|
17 participants
n=115 Participants
|
16 participants
n=40 Participants
|
16 participants
n=8 Participants
|
16 participants
n=62 Participants
|
130 participants
n=95 Participants
|
PRIMARY outcome
Timeframe: 15 daysPopulation: All efficacy analyses were conducted based on the modified intent-to-treat (MITT) analysis population, comprised of all randomized subjects who receive at least 1 dose of study drug and have at least 1 post-baseline measurement of total serum testosterone.
Percentage of subjects achieving a 24-hour average total serum testosterone concentration (Cavg,0-24h) in the range of 300 to 1050 ng/dL after 15 days of treatment with TSX-002. PK samples taken at 0 ,2 ,4, 5 ,6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8 ,12, 13, 14, 15, 16, 17, 18, 20, 24 hours post-dose after 15 days of treatment for Part 4.
Outcome measures
| Measure |
Part 1: 120 mg BID
n=17 Participants
Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 1: 240 mg BID
n=17 Participants
Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 2: 120 mg BID
n=17 Participants
Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 1: 60 mg BID
n=17 Participants
Oral TSX-002 60 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 1: 60 mg TID
n=17 Participants
Oral TSX-002 60 mg three times daily (TID) for 15 days
|
Part 4 Cohort 2: 90 mg BID
n=16 Participants
Oral TSX-002 90 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 2: 90 mg TID
n=16 Participants
Oral TSX-002 90 mg TID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 3: 180 mg QD
n=16 Participants
Oral TSX-002 180 mg once daily (QD) for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 4: 120 mg BID
n=16 Participants
Oral TSX-002 120 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Achieving a 24 Hour Average Total Serum Testosterone Concentration (Cavg,0-24h) in the Range of 300 to 1050 ng/dL After 15 Days of Treatment With TSX-002
|
59 percentage of participants
|
31 percentage of participants
|
35 percentage of participants
|
41 percentage of participants
|
53 percentage of participants
|
19 percentage of participants
|
20 percentage of participants
|
31 percentage of participants
|
27 percentage of participants
|
SECONDARY outcome
Timeframe: 15 daysPopulation: All efficacy analyses were conducted based on the modified intent-to-treat (MITT) analysis population, comprised of all randomized subjects who receive at least 1 dose of study drug and have at least 1 post-baseline measurement of total serum testosterone.
Cmax. PK samples taken at 0, 2, 4, 5, 6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 13, 14, 15, 16, 17,18, 20, 24 hours post-dose after 15 days of treatment for Part 4.
Outcome measures
| Measure |
Part 1: 120 mg BID
n=17 Participants
Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 1: 240 mg BID
n=17 Participants
Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 2: 120 mg BID
n=17 Participants
Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 1: 60 mg BID
n=17 Participants
Oral TSX-002 60 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 1: 60 mg TID
n=17 Participants
Oral TSX-002 60 mg three times daily (TID) for 15 days
|
Part 4 Cohort 2: 90 mg BID
n=16 Participants
Oral TSX-002 90 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 2: 90 mg TID
n=16 Participants
Oral TSX-002 90 mg TID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 3: 180 mg QD
n=16 Participants
Oral TSX-002 180 mg once daily (QD) for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 4: 120 mg BID
n=16 Participants
Oral TSX-002 120 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With Cmax ≤ 1500 ng/dL After 15 Days of Treatment 2. Percentage of Subjects With Cmax ≥ 1800 and ≤ 2500 ng/dL After 15 Days of BID Treatment 3. Percentage of Subjects With Cmax > 2500 ng/dL After 15 Days of BID Treatment
Percentage of subjects with Cmax ≤ 1500 ng/dL afte
|
100 percentage of subjects
|
100 percentage of subjects
|
94.1 percentage of subjects
|
100 percentage of subjects
|
100 percentage of subjects
|
100 percentage of subjects
|
100 percentage of subjects
|
100 percentage of subjects
|
93.75 percentage of subjects
|
|
Percentage of Subjects With Cmax ≤ 1500 ng/dL After 15 Days of Treatment 2. Percentage of Subjects With Cmax ≥ 1800 and ≤ 2500 ng/dL After 15 Days of BID Treatment 3. Percentage of Subjects With Cmax > 2500 ng/dL After 15 Days of BID Treatment
Percentage of subjects with Cmax ≥ 1800 and ≤ 2500
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
6.25 percentage of subjects
|
|
Percentage of Subjects With Cmax ≤ 1500 ng/dL After 15 Days of Treatment 2. Percentage of Subjects With Cmax ≥ 1800 and ≤ 2500 ng/dL After 15 Days of BID Treatment 3. Percentage of Subjects With Cmax > 2500 ng/dL After 15 Days of BID Treatment
Percentage of subjects with Cmax > 2500 ng/dL afte
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
0 percentage of subjects
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hrsPopulation: All subjects that received 120 mg TSX-002 under defined Treatment conditions (timing of high-calorie, high-fat meal).
PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3. Mean of Cavg values from all time points for 14 subjects.
Outcome measures
| Measure |
Part 1: 120 mg BID
n=14 Participants
Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 1: 240 mg BID
n=14 Participants
Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 2: 120 mg BID
n=14 Participants
Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 1: 60 mg BID
Oral TSX-002 60 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 1: 60 mg TID
Oral TSX-002 60 mg three times daily (TID) for 15 days
|
Part 4 Cohort 2: 90 mg BID
Oral TSX-002 90 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 2: 90 mg TID
Oral TSX-002 90 mg TID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 3: 180 mg QD
Oral TSX-002 180 mg once daily (QD) for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 4: 120 mg BID
Oral TSX-002 120 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cavg 0-24 Hrs (ng/dL) After 120 mg Dose
|
296 ng/dL
Standard Deviation 108
|
297 ng/dL
Standard Deviation 75
|
273 ng/dL
Standard Deviation 109
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hrsPopulation: All subjects that received 120 mg TSX-002 under defined Treatment conditions (timing of high-calorie, high-fat meal).
AUC 0-24 hrs with PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3.
Outcome measures
| Measure |
Part 1: 120 mg BID
n=14 Participants
Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 1: 240 mg BID
n=14 Participants
Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 2: 120 mg BID
n=14 Participants
Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 1: 60 mg BID
Oral TSX-002 60 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 1: 60 mg TID
Oral TSX-002 60 mg three times daily (TID) for 15 days
|
Part 4 Cohort 2: 90 mg BID
Oral TSX-002 90 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 2: 90 mg TID
Oral TSX-002 90 mg TID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 3: 180 mg QD
Oral TSX-002 180 mg once daily (QD) for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 4: 120 mg BID
Oral TSX-002 120 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
|---|---|---|---|---|---|---|---|---|---|
|
AUC 0-24 Hrs After 120 mg Dose of TSX-002
|
1941 hr×ng/dL
Standard Deviation 1198
|
2117 hr×ng/dL
Standard Deviation 1351
|
1516 hr×ng/dL
Standard Deviation 1217
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 3: A-B-C 120 mg QD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1: 120 mg BID
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1: 240 mg BID
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part 2: 120 mg BID
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 3: B-C-A 120 mg QD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 3: C-A-B 120 mg QD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 4 Cohort 1: 60 mg BID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 4 Cohort 1: 60 mg TID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 4 Cohort 2: 90 mg BID
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 4 Cohort 2: 90 mg TID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 4 Cohort 3: 180 mg QD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 4 Cohort 4: 120 mg BID
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 |
Part 3: A-B-C 120 mg QD
n=4 participants at risk
Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 1: 120 mg BID
n=17 participants at risk
Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 1: 240 mg BID
n=17 participants at risk
Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 2: 120 mg BID
n=17 participants at risk
Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 3: B-C-A 120 mg QD
n=5 participants at risk
Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 3: C-A-B 120 mg QD
n=5 participants at risk
Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
* Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
* Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 1: 60 mg BID
n=17 participants at risk
Oral TSX-002 60 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 1: 60 mg TID
n=17 participants at risk
Oral TSX-002 60 mg TID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 2: 90 mg BID
n=16 participants at risk
Oral TSX-002 90 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 2: 90 mg TID
n=16 participants at risk
Oral TSX-002 90 mg TID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 3: 180 mg QD
n=16 participants at risk
Oral TSX-002 180 mg once daily (QD) for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
Part 4 Cohort 4: 120 mg BID
n=16 participants at risk
Oral TSX-002 120 mg BID for 15 days
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
6.2%
1/16 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
6.2%
1/16 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
6.2%
1/16 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
20.0%
1/5 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
General disorders
Asthenia
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
General disorders
Catheter site phlebitis
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
6.2%
1/16 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
General disorders
Chest pain
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
General disorders
Fatigue
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
6.2%
1/16 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
20.0%
1/5 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
General disorders
Oedema
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
6.2%
1/16 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
General disorders
Sluggishness
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
6.2%
1/16 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
6.2%
1/16 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
20.0%
1/5 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Investigations
Blood potassium increased
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
20.0%
1/5 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
6.2%
1/16 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
11.8%
2/17 • Number of events 2 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
12.5%
2/16 • Number of events 2 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
6.2%
1/16 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
6.2%
1/16 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
6.2%
1/16 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
6.2%
1/16 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Psychiatric disorders
Anger
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
6.2%
1/16 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
6.2%
1/16 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
5.9%
1/17 • Number of events 1 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/5 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/17 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
0.00%
0/16 • The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.
|
Additional Information
Michael Oefelein, MD, Chief Medical Officer
TesoRx Pharma LLC
Phone: 909-595-0500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Restriction Description: At 60 days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Site shall provide to Sponsor a copy and allow Sponsor 60 days to review and comment and provide written permission prior to publication.
- Publication restrictions are in place
Restriction type: OTHER