Trial Outcomes & Findings for Safety, Tolerability and Preliminary Efficacy of AZD5213 in Combination With Pregabalin in Subjects With PDN and Good Pain Reporting Ability (NCT NCT01928381)
NCT ID: NCT01928381
Last Updated: 2016-10-03
Results Overview
Brief pain Index - diabetic painful neuropathy (BPI-DPN) - average daily pain, Item 5 (final 2 day diary + in clinic assessment at end of 3 week treatment period)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
150 participants
Primary outcome timeframe
3 weeks of treatment
Results posted on
2016-10-03
Participant Flow
143 adults with painful diabetic neuropathy were screened, in a total of 146 screenings, 83 met eligibility criteria and entered Pain Training - Part 1. To be randomized into Part 2 (3 period treatment crossover study), participants had to successfully complete Part 1 Pain Training and meet all study entry criteria at Visit 6 (\~Day 36) .
Crossover data starting with First Intervention excludes 3 participants who were randomized but not treated in the double-blind crossover periods. The 3 are included as withdrawals in Part 1 - Placebo run-in (single blind) period.
Participant milestones
| Measure |
Part 1 - Pain Training
Part 1 - Screening, Pain Training, placebo run-in eligibility for Part 2
|
Sequence 1
Sequence 1 - 1st placebo, 2nd pregabalin, 3rd AZD5213 + pregabalin
|
Sequence 2
Sequence 2 - 1st Placebo, 2nd AZD5213 + pregabalin, 3rd pregabalin
|
Sequence 3
Sequence 3 - 1st pregabalin, 2nd placebo, 3rd AZD5213 + pregabalin
|
Sequence 4
Sequence 4 - 1st pregabalin, 2nd AZD5213 + pregabalin, 3rd placebo
|
Sequence 5
Sequence 5 - 1st AZD5213 + pregabalin, 2nd placebo, 3rd pregabalin
|
Sequence 6
Sequence 6 - 1st AZD5213 + pregabalin, 2nd pregabalin, 3rd placebo
|
|---|---|---|---|---|---|---|---|
|
Screening for Pain Training
STARTED
|
143
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Screening for Pain Training
COMPLETED
|
83
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Screening for Pain Training
NOT COMPLETED
|
60
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 - Pain Training
STARTED
|
83
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 - Pain Training
COMPLETED
|
48
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 - Pain Training
NOT COMPLETED
|
35
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo run-in & Part 2 Eligibility
STARTED
|
48
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo run-in & Part 2 Eligibility
COMPLETED
|
34
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo run-in & Part 2 Eligibility
NOT COMPLETED
|
14
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 - First Intervention
STARTED
|
0
|
6
|
6
|
6
|
4
|
6
|
6
|
|
Part 2 - First Intervention
COMPLETED
|
0
|
6
|
4
|
5
|
4
|
5
|
5
|
|
Part 2 - First Intervention
NOT COMPLETED
|
0
|
0
|
2
|
1
|
0
|
1
|
1
|
|
Washout First Intervention
STARTED
|
0
|
6
|
4
|
5
|
4
|
5
|
5
|
|
Washout First Intervention
COMPLETED
|
0
|
6
|
4
|
5
|
3
|
5
|
5
|
|
Washout First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part 2 - Second Intervention
STARTED
|
0
|
6
|
4
|
5
|
3
|
5
|
5
|
|
Part 2 - Second Intervention
COMPLETED
|
0
|
5
|
4
|
4
|
3
|
5
|
5
|
|
Part 2 - Second Intervention
NOT COMPLETED
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Washout Second Intervention
STARTED
|
0
|
5
|
4
|
4
|
3
|
5
|
5
|
|
Washout Second Intervention
COMPLETED
|
0
|
5
|
4
|
4
|
3
|
5
|
5
|
|
Washout Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 - Third Intervention
STARTED
|
0
|
5
|
4
|
4
|
3
|
5
|
5
|
|
Part 2 - Third Intervention
COMPLETED
|
0
|
5
|
4
|
4
|
3
|
5
|
5
|
|
Part 2 - Third Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 - Post Third Intervention
STARTED
|
0
|
5
|
4
|
4
|
3
|
5
|
5
|
|
Part 2 - Post Third Intervention
COMPLETED
|
0
|
5
|
3
|
4
|
3
|
5
|
5
|
|
Part 2 - Post Third Intervention
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1 - Pain Training
Part 1 - Screening, Pain Training, placebo run-in eligibility for Part 2
|
Sequence 1
Sequence 1 - 1st placebo, 2nd pregabalin, 3rd AZD5213 + pregabalin
|
Sequence 2
Sequence 2 - 1st Placebo, 2nd AZD5213 + pregabalin, 3rd pregabalin
|
Sequence 3
Sequence 3 - 1st pregabalin, 2nd placebo, 3rd AZD5213 + pregabalin
|
Sequence 4
Sequence 4 - 1st pregabalin, 2nd AZD5213 + pregabalin, 3rd placebo
|
Sequence 5
Sequence 5 - 1st AZD5213 + pregabalin, 2nd placebo, 3rd pregabalin
|
Sequence 6
Sequence 6 - 1st AZD5213 + pregabalin, 2nd pregabalin, 3rd placebo
|
|---|---|---|---|---|---|---|---|
|
Screening for Pain Training
Did not qualify (inclusion/Exclusion)
|
60
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 - Pain Training
Pain training criteria not met
|
29
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 - Pain Training
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 - Pain Training
Lost to Follow-up
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 - Pain Training
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo run-in & Part 2 Eligibility
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo run-in & Part 2 Eligibility
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo run-in & Part 2 Eligibility
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo run-in & Part 2 Eligibility
Eligibility for Part 2 not met
|
10
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 - First Intervention
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part 2 - First Intervention
Study specific withdrawal criteria
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part 2 - First Intervention
Eligibility criterion not met
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Part 2 - First Intervention
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Washout First Intervention
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part 2 - Second Intervention
Lost to Follow-up
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Part 2 - Post Third Intervention
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability and Preliminary Efficacy of AZD5213 in Combination With Pregabalin in Subjects With PDN and Good Pain Reporting Ability
Baseline characteristics by cohort
| Measure |
Overall Study
n=83 Participants
Overall Study - Starting with Part 1
|
|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 9.25 • n=93 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
78 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 3 weeks of treatmentPopulation: Full Analysis set
Brief pain Index - diabetic painful neuropathy (BPI-DPN) - average daily pain, Item 5 (final 2 day diary + in clinic assessment at end of 3 week treatment period)
Outcome measures
| Measure |
Part 2 - Placebo
n=29 Participants
Part 2 - placebo crossover periods
|
Part 2 - Pregabalin + AZD5213
n=27 Participants
Part 2 - Combined pregabalin + AZD5213 crossover periods
|
Part 2 - Pregabalin
n=30 Participants
Part 2 pregabalin crossover periods
|
|---|---|---|---|
|
Brief Pain Index - Item 5, Average Daily Pain Score (Range 0-10) Higher Values Indicate Worse Pain
|
4.24 Average daily pain score
Standard Error 0.38
|
4.41 Average daily pain score
Standard Error 0.38
|
4.27 Average daily pain score
Standard Error 0.38
|
POST_HOC outcome
Timeframe: 3 weeks of treatmentPopulation: Per Protocol
Brief pain Index - diabetic painful neuropathy (BPI-DPN) - average daily pain, Item 5 (final 2 day home diary + in clinic assessment at end of 3 week treatment)
Outcome measures
| Measure |
Part 2 - Placebo
n=20 Participants
Part 2 - placebo crossover periods
|
Part 2 - Pregabalin + AZD5213
n=20 Participants
Part 2 - Combined pregabalin + AZD5213 crossover periods
|
Part 2 - Pregabalin
n=20 Participants
Part 2 pregabalin crossover periods
|
|---|---|---|---|
|
Brief Pain Index - Item 5, Average Daily Pain Score (Range 0-10) Higher Score Indicates Worse Pain - Per Protocol
|
4.46 Average daily pain score
Standard Error 0.45
|
4.35 Average daily pain score
Standard Error 0.45
|
4.04 Average daily pain score
Standard Error 0.45
|
Adverse Events
Part 1
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Part 2 - Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part 2 - Pregabalin + AZD5213
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Part 2 - Pregabalin
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Overall Study
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1
n=83 participants at risk
Part 1 - Pain training + 1 week of single blind placebo
|
Part 2 - Placebo
n=30 participants at risk
Part 2 - placebo crossover periods
|
Part 2 - Pregabalin + AZD5213
n=28 participants at risk
Part 2 - Combined pregabalin + AZD5213 crossover periods
|
Part 2 - Pregabalin
n=30 participants at risk
Part 2 pregabalin crossover periods
|
Overall Study
n=83 participants at risk
Overall Study: Part 1 and Part 2
|
|---|---|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.3%
1/30 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.3%
1/30 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 2 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.3%
1/30 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.3%
1/30 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.6%
1/28 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.3%
1/30 • Number of events 2 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 2 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.6%
1/28 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Psychiatric disorders
Restlessness
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
6.7%
2/30 • Number of events 2 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.6%
1/28 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
4.8%
4/83 • Number of events 4 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Infections and infestations
Herper zoster
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.6%
1/28 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Infections and infestations
Skin infection
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.3%
1/30 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Infections and infestations
Pneumonia
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
General disorders
Oedema peripheral
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
7.1%
2/28 • Number of events 2 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.3%
1/30 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
2.4%
2/83 • Number of events 3 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
General disorders
Thirst
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.3%
1/30 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
General disorders
Influenza like illness
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
General disorders
Non cardiac chest pain
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.6%
1/28 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.6%
1/28 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Injury, poisoning and procedural complications
Nail injury
|
2.4%
2/83 • Number of events 2 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
2.4%
2/83 • Number of events 2 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Injury, poisoning and procedural complications
Concussion
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Injury, poisoning and procedural complications
Laceration
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Injury, poisoning and procedural complications
Post-traumatic neck pain
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Nervous system disorders
Headache
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
7.1%
2/28 • Number of events 2 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
6.7%
2/30 • Number of events 2 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
4.8%
4/83 • Number of events 4 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.6%
1/28 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.3%
1/30 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Nervous system disorders
Dizziness
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.3%
1/30 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
7.1%
2/28 • Number of events 2 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
13.3%
4/30 • Number of events 4 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
6.0%
5/83 • Number of events 7 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
7.1%
2/28 • Number of events 2 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.3%
1/30 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
2.4%
2/83 • Number of events 3 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Gastrointestinal disorders
Dry mouth
|
3.6%
3/83 • Number of events 3 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
6.7%
2/30 • Number of events 2 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
6.0%
5/83 • Number of events 5 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.6%
1/28 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
2.4%
2/83 • Number of events 2 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Gastrointestinal disorders
Dyspepsia
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.6%
1/28 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
2.4%
2/83 • Number of events 2 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Gastrointestinal disorders
Nausea
|
2.4%
2/83 • Number of events 2 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.3%
1/30 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.6%
3/83 • Number of events 3 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Gastrointestinal disorders
Toothache
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.3%
1/30 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
2.4%
2/83 • Number of events 2 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Metabolism and nutrition disorders
Hyperphagia
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.6%
1/28 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.3%
1/30 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 2 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.6%
1/28 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.3%
1/30 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 2 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Metabolism and nutrition disorders
Diabetes mellitis
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.3%
1/30 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.6%
1/28 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.3%
1/30 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.3%
1/30 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
7.1%
2/28 • Number of events 2 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.3%
1/30 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.6%
3/83 • Number of events 4 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.3%
1/30 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
2.4%
2/83 • Number of events 2 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Musculoskeletal and connective tissue disorders
Exotosis
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.6%
1/28 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Skin and subcutaneous tissue disorders
Hyperhydrosis
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.3%
1/30 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.3%
1/30 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 2 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Blood and lymphatic system disorders
Lymphadenopaty
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.3%
1/30 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Reproductive system and breast disorders
Priapism
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.6%
1/28 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.3%
1/30 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngael pain
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Renal and urinary disorders
Pollakiuria
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/83 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
3.3%
1/30 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/28 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
0.00%
0/30 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
1.2%
1/83 • Number of events 1 • (5 months)
From start of Part 1 through follow up visit 7 to 14 days after last dose in Part 2, 3 period crossover
|
Additional Information
Joel Posener, MD - Head Early Clinical Development
AstraZeneca Pharmaceuticals LP, Neuroscience Innovative Medicine Unit
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60