Trial Outcomes & Findings for Phase 1/2A Study of TRC253, an Androgen Receptor Antagonist, in Metastatic Castration-resistant Prostate Cancer Patients (NCT NCT02987829)
NCT ID: NCT02987829
Last Updated: 2021-04-23
Results Overview
The trial began with single patient dose escalation rules. If 1 of 1 patients at a given dose experienced a DLT, the study transitioned to a 3+3 design. If 1 of 3 patients experienced a DLT, the dose level was expanded to 6 patients. The maximum tolerated dose (MTD) would have been exceeded if ≥ 33% of patients experience DLT at a given dose level. DLT occurred when a patient had 1 or more toxicities outlined in the protocol that was considered at least possibly related to TRC253 during the first 5 weeks of study participation in the trial. In addition, any dose level could be expanded to further explore PK (the target PK concentration associated with activity in preclinical models was 335 ng/mL). The number of DLTs by dose cohort have been presented.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
72 participants
Primary outcome timeframe
5 weeks
Results posted on
2021-04-23
Participant Flow
Participant milestones
| Measure |
40 mg TRC253/Daily
Single-agent TRC253 to be administered as oral capsules once daily.
|
80 mg TRC253/Daily
Single-agent TRC253 to be administered as oral capsules once daily.
|
160 mg TRC253/Daily
Single-agent TRC253 to be administered as oral capsules once daily.
|
240 mg TRC253/Daily
Single-agent TRC253 to be administered as oral capsules once daily.
|
280 mg TRC253/Daily
Single-agent TRC253 to be administered as oral capsules once daily.
|
320 mg TRC253/Daily
Single-agent TRC253 to be administered as oral capsules once daily.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
2
|
7
|
51
|
10
|
|
Overall Study
COMPLETED
|
1
|
1
|
2
|
7
|
51
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 1/2A Study of TRC253, an Androgen Receptor Antagonist, in Metastatic Castration-resistant Prostate Cancer Patients
Baseline characteristics by cohort
| Measure |
40 mg TRC253/Daily
n=1 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
80 mg TRC253/Daily
n=1 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
160 mg TRC253/Daily
n=2 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
240 mg TRC253/Daily
n=7 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
280 mg TRC253/Daily
n=51 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
320 mg TRC253/Daily
n=10 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
19 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
39 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
53 Participants
n=3 Participants
|
|
Age, Continuous
|
80 Years
n=99 Participants
|
65 Years
n=107 Participants
|
78 Years
n=206 Participants
|
68 Years
n=7 Participants
|
73 Years
n=31 Participants
|
67 Years
n=30 Participants
|
72 Years
n=3 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
51 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
72 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
42 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
57 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other (Patient declined to answer)
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
7 participants
n=7 Participants
|
51 participants
n=31 Participants
|
10 participants
n=30 Participants
|
72 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 5 weeksPopulation: All patients who received at least a portion of a dose of TRC253 are included in the analysis.
The trial began with single patient dose escalation rules. If 1 of 1 patients at a given dose experienced a DLT, the study transitioned to a 3+3 design. If 1 of 3 patients experienced a DLT, the dose level was expanded to 6 patients. The maximum tolerated dose (MTD) would have been exceeded if ≥ 33% of patients experience DLT at a given dose level. DLT occurred when a patient had 1 or more toxicities outlined in the protocol that was considered at least possibly related to TRC253 during the first 5 weeks of study participation in the trial. In addition, any dose level could be expanded to further explore PK (the target PK concentration associated with activity in preclinical models was 335 ng/mL). The number of DLTs by dose cohort have been presented.
Outcome measures
| Measure |
40 mg TRC253/Daily
n=1 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
80 mg TRC253/Daily
n=1 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
160 mg TRC253/Daily
n=2 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
240 mg TRC253/Daily
n=7 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
280 mg TRC253/Daily
n=51 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
320 mg TRC253/Daily
n=10 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
|---|---|---|---|---|---|---|
|
Number of Patients Who Experience Dose Limiting Toxicities by Dose Level
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Patients with a baseline PSA and at least 1 on study PSA that were confirmed at least 4 weeks later.
Serum prostate-specific antigen (PSA) response according to Prostate Cancer Working Group (PCWG3) criteria is defined as at least a 50% decrease in PSA from baseline confirmed at least 4 weeks later
Outcome measures
| Measure |
40 mg TRC253/Daily
n=1 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
80 mg TRC253/Daily
n=1 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
160 mg TRC253/Daily
n=2 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
240 mg TRC253/Daily
n=7 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
280 mg TRC253/Daily
n=51 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
320 mg TRC253/Daily
n=10 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
|---|---|---|---|---|---|---|
|
Number of Participants With a Serum Prostate-specific Antigen (PSA) Response According to Prostate Cancer Working Group (PCWG3) Criteria
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Patients who received at least a portion of a dose of TRC253 with a baseline ECG and at least 1 on study ECG.
Maximum change in QTcF from baseline by dose level
Outcome measures
| Measure |
40 mg TRC253/Daily
n=1 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
80 mg TRC253/Daily
Single-agent TRC253 to be administered as oral capsules once daily.
|
160 mg TRC253/Daily
n=1 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
240 mg TRC253/Daily
n=7 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
280 mg TRC253/Daily
n=50 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
320 mg TRC253/Daily
n=8 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
|---|---|---|---|---|---|---|
|
Maximum Change in QTcF
|
9 msec
Interval 9.0 to 9.0
|
—
|
22 msec
Interval 22.0 to 22.0
|
44.62 msec
Interval 32.0 to 64.0
|
37.56 msec
Interval 0.0 to 77.0
|
42.63 msec
Interval 5.0 to 93.0
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: TRC253 4 week FDHT-PET response mean SUV based on the 5 hottest lesions (uncorrected)
To confirm the recommended phase 2 dose (RP2D), patients at select dose levels will undergo positron emission tomography scan (PET) scans using fluoro-5alpha-dihydrotestosterone (FDHT), a radiopharmaceutical specifically designed to image binding to androgen receptor (AR). Imaging occurred at one center under their existing investigational new drug application (IND) and institutional protocol. A negative change from baseline in the standard uptake value indicate a decrease in metabolic activity of the tumor and indicate increased receptor occupancy of TRC253.
Outcome measures
| Measure |
40 mg TRC253/Daily
Single-agent TRC253 to be administered as oral capsules once daily.
|
80 mg TRC253/Daily
Single-agent TRC253 to be administered as oral capsules once daily.
|
160 mg TRC253/Daily
n=1 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
240 mg TRC253/Daily
n=2 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
280 mg TRC253/Daily
n=1 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
320 mg TRC253/Daily
n=2 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Standard Uptake Value (SUV) to Assess TRC253 Receptor Occupancy
|
—
|
—
|
-34.1 Percent Change from Baseline
Interval -34.1 to -34.1
|
-2.81 Percent Change from Baseline
Interval -37.32 to 31.71
|
27.78 Percent Change from Baseline
Interval 27.78 to 27.78
|
-45.88 Percent Change from Baseline
Interval -57.32 to -34.43
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: In order to be eligible for efficacy analysis patients must have had a baseline CT scan and at least 1 on study CT scan.
Preliminary anti-tumor effects of TRC253 as assessed by median time to progression by Prostate Cancer Working Group 3 (PCWG3) criteria by dose level
Outcome measures
| Measure |
40 mg TRC253/Daily
n=1 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
80 mg TRC253/Daily
n=1 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
160 mg TRC253/Daily
n=2 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
240 mg TRC253/Daily
n=7 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
280 mg TRC253/Daily
n=44 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
320 mg TRC253/Daily
n=8 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
|---|---|---|---|---|---|---|
|
Median Time to Progression by Dose Level
|
8.7 months
The upper and lower confidence level cannot be calculated due to the small sample size
|
9.5 months
The upper and lower confidence level cannot be calculated due to the small sample size
|
4.8 months
The upper and lower confidence level cannot be calculated due to the small sample size
|
3.75 months
Interval 2.01 to
The upper confidence level cannot be calculated due to the small sample size
|
4.64 months
Interval 2.04 to 7.17
|
12.20 months
Interval 1.91 to
The upper confidence level cannot be calculated due to the small sample size
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Patients who received at least 75% of planned continuous daily dosing after 28 days of daily dosing enrolled in part 1 of the study.
Determine the number of patients who achieved the target concentration of TRC253 at steady state (target efficacy concentration of 335 ng/mL based on preclinical models).
Outcome measures
| Measure |
40 mg TRC253/Daily
n=1 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
80 mg TRC253/Daily
n=1 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
160 mg TRC253/Daily
n=2 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
240 mg TRC253/Daily
n=7 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
280 mg TRC253/Daily
n=4 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
320 mg TRC253/Daily
n=6 Participants
Single-agent TRC253 to be administered as oral capsules once daily.
|
|---|---|---|---|---|---|---|
|
Number of Patients Who Achieved the Target Concentration of TRC253 at Steady State
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
Adverse Events
40 mg TRC253/Daily
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
80 mg TRC253/Daily
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
160 mg TRC253/Daily
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
240 mg TRC253/Daily
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
280 mg TRC253/Daily
Serious events: 13 serious events
Other events: 48 other events
Deaths: 1 deaths
320 mg TRC253/Daily
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
40 mg TRC253/Daily
n=1 participants at risk
Single-agent TRC253 to be administered as oral capsules once daily.
|
80 mg TRC253/Daily
n=1 participants at risk
Single-agent TRC253 to be administered as oral capsules once daily.
|
160 mg TRC253/Daily
n=2 participants at risk
Single-agent TRC253 to be administered as oral capsules once daily.
|
240 mg TRC253/Daily
n=7 participants at risk
Single-agent TRC253 to be administered as oral capsules once daily.
|
280 mg TRC253/Daily
n=51 participants at risk
Single-agent TRC253 to be administered as oral capsules once daily.
|
320 mg TRC253/Daily
n=10 participants at risk
Single-agent TRC253 to be administered as oral capsules once daily.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
100.0%
1/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
100.0%
1/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Infections and infestations
Device related infection
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
General disorders
Disease progression
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Surgical and medical procedures
Intramedullary rod insertion
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningeal neoplasm
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
3.9%
2/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
3.9%
2/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
Other adverse events
| Measure |
40 mg TRC253/Daily
n=1 participants at risk
Single-agent TRC253 to be administered as oral capsules once daily.
|
80 mg TRC253/Daily
n=1 participants at risk
Single-agent TRC253 to be administered as oral capsules once daily.
|
160 mg TRC253/Daily
n=2 participants at risk
Single-agent TRC253 to be administered as oral capsules once daily.
|
240 mg TRC253/Daily
n=7 participants at risk
Single-agent TRC253 to be administered as oral capsules once daily.
|
280 mg TRC253/Daily
n=51 participants at risk
Single-agent TRC253 to be administered as oral capsules once daily.
|
320 mg TRC253/Daily
n=10 participants at risk
Single-agent TRC253 to be administered as oral capsules once daily.
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Renal and urinary disorders
Haematuria
|
100.0%
1/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
5.9%
3/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
100.0%
1/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
5.9%
3/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
100.0%
1/1 • 18 months
Duration of participation +28 days
|
100.0%
1/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
7.8%
4/51 • 18 months
Duration of participation +28 days
|
40.0%
4/10 • 18 months
Duration of participation +28 days
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
100.0%
1/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
28.6%
2/7 • 18 months
Duration of participation +28 days
|
15.7%
8/51 • 18 months
Duration of participation +28 days
|
20.0%
2/10 • 18 months
Duration of participation +28 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
100.0%
1/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
28.6%
2/7 • 18 months
Duration of participation +28 days
|
9.8%
5/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
100.0%
1/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
5.9%
3/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
100.0%
1/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
28.6%
2/7 • 18 months
Duration of participation +28 days
|
5.9%
3/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
100.0%
1/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
100.0%
1/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
15.7%
8/51 • 18 months
Duration of participation +28 days
|
40.0%
4/10 • 18 months
Duration of participation +28 days
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
100.0%
1/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
42.9%
3/7 • 18 months
Duration of participation +28 days
|
27.5%
14/51 • 18 months
Duration of participation +28 days
|
50.0%
5/10 • 18 months
Duration of participation +28 days
|
|
General disorders
Fatigue
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
100.0%
1/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
17.6%
9/51 • 18 months
Duration of participation +28 days
|
60.0%
6/10 • 18 months
Duration of participation +28 days
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
100.0%
1/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
100.0%
1/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
100.0%
1/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
7.8%
4/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
100.0%
1/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
100.0%
1/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
100.0%
1/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
100.0%
1/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
100.0%
1/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
28.6%
2/7 • 18 months
Duration of participation +28 days
|
11.8%
6/51 • 18 months
Duration of participation +28 days
|
30.0%
3/10 • 18 months
Duration of participation +28 days
|
|
Investigations
Weight decreased
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
100.0%
1/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
9.8%
5/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Investigations
White blood cell count decreased
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
100.0%
1/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
3.9%
2/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Investigations
White blood cell count increased
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
100.0%
1/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
11.8%
6/51 • 18 months
Duration of participation +28 days
|
20.0%
2/10 • 18 months
Duration of participation +28 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
42.9%
3/7 • 18 months
Duration of participation +28 days
|
15.7%
8/51 • 18 months
Duration of participation +28 days
|
50.0%
5/10 • 18 months
Duration of participation +28 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
13.7%
7/51 • 18 months
Duration of participation +28 days
|
20.0%
2/10 • 18 months
Duration of participation +28 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
11.8%
6/51 • 18 months
Duration of participation +28 days
|
20.0%
2/10 • 18 months
Duration of participation +28 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
5.9%
3/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
28.6%
2/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
3.9%
2/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
3.9%
2/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
3.9%
2/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Infections and infestations
Lung infection
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
17.6%
9/51 • 18 months
Duration of participation +28 days
|
40.0%
4/10 • 18 months
Duration of participation +28 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
General disorders
Pyrexia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
5.9%
3/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
General disorders
Temperature intolerance
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
50.0%
1/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Infections and infestations
Device related infection
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
28.6%
2/7 • 18 months
Duration of participation +28 days
|
19.6%
10/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Eye disorders
Diplopia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
3.9%
2/51 • 18 months
Duration of participation +28 days
|
20.0%
2/10 • 18 months
Duration of participation +28 days
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Eye disorders
Eye discharge
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
General disorders
Facial pain
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
5.9%
3/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Vascular disorders
Hot flush
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
28.6%
2/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
5.9%
3/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Investigations
Lipase increased
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Infections and infestations
Oral herpes
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
General disorders
Pain
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
42.9%
3/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
28.6%
2/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
3.9%
2/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Infections and infestations
Abscess
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
3.9%
2/51 • 18 months
Duration of participation +28 days
|
20.0%
2/10 • 18 months
Duration of participation +28 days
|
|
General disorders
Asthenia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
5.9%
3/51 • 18 months
Duration of participation +28 days
|
20.0%
2/10 • 18 months
Duration of participation +28 days
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
9.8%
5/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
General disorders
Chills
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Eye disorders
Corneal neovascularisation
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
11.8%
6/51 • 18 months
Duration of participation +28 days
|
20.0%
2/10 • 18 months
Duration of participation +28 days
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
5.9%
3/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
5.9%
3/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Eye disorders
Eye swelling
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
General disorders
Gait disturbance
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
5.9%
3/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
3.9%
2/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
9.8%
5/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
5.9%
3/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
7.8%
4/51 • 18 months
Duration of participation +28 days
|
20.0%
2/10 • 18 months
Duration of participation +28 days
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Vascular disorders
Subclavian artery thrombosis
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
9.8%
5/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
5.9%
3/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Renal and urinary disorders
Neurogenic Bladder
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
3.9%
2/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
3.9%
2/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Nervous system disorders
Presyncope
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
3.9%
2/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
3.9%
2/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
3.9%
2/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Musculoskeletal and connective tissue disorders
Pelvic Pain
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Nervous system disorders
Sciatica
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
3.9%
2/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
11.8%
6/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
9.8%
5/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Renal and urinary disorders
Vesicocutaneous fistula
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
2.0%
1/51 • 18 months
Duration of participation +28 days
|
0.00%
0/10 • 18 months
Duration of participation +28 days
|
|
Psychiatric disorders
Agitation
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Investigations
Blood amylase increased
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
14.3%
1/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
3.9%
2/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/1 • 18 months
Duration of participation +28 days
|
0.00%
0/2 • 18 months
Duration of participation +28 days
|
0.00%
0/7 • 18 months
Duration of participation +28 days
|
0.00%
0/51 • 18 months
Duration of participation +28 days
|
10.0%
1/10 • 18 months
Duration of participation +28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60