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Phase 1/2A Study of TRC253, an Androgen Receptor Antagonist, in Metastatic Castration-resistant Prostate Cancer Patients

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ClinicalTrials.gov Identifier: NCT02987829
Recruitment Status : Completed
First Posted : December 9, 2016
Results First Posted : April 23, 2021
Last Update Posted : April 23, 2021
Sponsor:
Collaborator:
Janssen Pharmaceutica N.V., Belgium
Information provided by (Responsible Party):
Tracon Pharmaceuticals Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Metastatic Castrate-resistant Prostate Cancer
Adenocarcinoma, Prostate
Intervention Drug: TRC253
Enrollment 72
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 40 mg TRC253/Daily 80 mg TRC253/Daily 160 mg TRC253/Daily 240 mg TRC253/Daily 280 mg TRC253/Daily 320 mg TRC253/Daily
Hide Arm/Group Description Single-agent TRC253 to be administered as oral capsules once daily. Single-agent TRC253 to be administered as oral capsules once daily. Single-agent TRC253 to be administered as oral capsules once daily. Single-agent TRC253 to be administered as oral capsules once daily. Single-agent TRC253 to be administered as oral capsules once daily. Single-agent TRC253 to be administered as oral capsules once daily.
Period Title: Overall Study
Started 1 1 2 7 51 10
Completed 1 1 2 7 51 10
Not Completed 0 0 0 0 0 0
Arm/Group Title 40 mg TRC253/Daily 80 mg TRC253/Daily 160 mg TRC253/Daily 240 mg TRC253/Daily 280 mg TRC253/Daily 320 mg TRC253/Daily Total
Hide Arm/Group Description Single-agent TRC253 to be administered as oral capsules once daily. Single-agent TRC253 to be administered as oral capsules once daily. Single-agent TRC253 to be administered as oral capsules once daily. Single-agent TRC253 to be administered as oral capsules once daily. Single-agent TRC253 to be administered as oral capsules once daily. Single-agent TRC253 to be administered as oral capsules once daily. Total of all reporting groups
Overall Number of Baseline Participants 1 1 2 7 51 10 72
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants 7 participants 51 participants 10 participants 72 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
2
  28.6%
12
  23.5%
5
  50.0%
19
  26.4%
>=65 years
1
 100.0%
1
 100.0%
2
 100.0%
5
  71.4%
39
  76.5%
5
  50.0%
53
  73.6%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants 1 participants 2 participants 7 participants 51 participants 10 participants 72 participants
80
(80 to 80)
65
(65 to 65)
78
(75 to 81)
68
(56 to 79)
73
(56 to 90)
67
(58 to 81)
72
(56 to 90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants 7 participants 51 participants 10 participants 72 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
1
 100.0%
1
 100.0%
2
 100.0%
7
 100.0%
51
 100.0%
10
 100.0%
72
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 1 participants 1 participants 2 participants 7 participants 51 participants 10 participants 72 participants
Asian
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
2
   3.9%
0
   0.0%
3
   4.2%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5
   9.8%
3
  30.0%
8
  11.1%
White
1
 100.0%
1
 100.0%
1
  50.0%
6
  85.7%
42
  82.4%
6
  60.0%
57
  79.2%
Other (Patient declined to answer)
0
   0.0%
0
   0.0%
1
  50.0%
0
   0.0%
2
   3.9%
1
  10.0%
4
   5.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 1 participants 2 participants 7 participants 51 participants 10 participants 72 participants
1 1 2 7 51 10 72
1.Primary Outcome
Title Number of Patients Who Experience Dose Limiting Toxicities by Dose Level
Hide Description 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.
Time Frame 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least a portion of a dose of TRC253 are included in the analysis.
Arm/Group Title 40 mg TRC253/Daily 80 mg TRC253/Daily 160 mg TRC253/Daily 240 mg TRC253/Daily 280 mg TRC253/Daily 320 mg TRC253/Daily
Hide Arm/Group Description:
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Overall Number of Participants Analyzed 1 1 2 7 51 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 280 mg TRC253/Daily
Comments Determination of the maximum tolerated dose.
Type of Statistical Test Other
Comments [Not Specified]
Other Statistical Analysis One dose limiting toxicity occurred at 320 mg daily of grade 3 QTc prolongation therefore the 280 mg dose was determined to be the maximum tolerated dose and selected as the phase 2 dose.
2.Secondary Outcome
Title Number of Participants With a Serum Prostate-specific Antigen (PSA) Response According to Prostate Cancer Working Group (PCWG3) Criteria
Hide Description 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
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with a baseline PSA and at least 1 on study PSA that were confirmed at least 4 weeks later.
Arm/Group Title 40 mg TRC253/Daily 80 mg TRC253/Daily 160 mg TRC253/Daily 240 mg TRC253/Daily 280 mg TRC253/Daily 320 mg TRC253/Daily
Hide Arm/Group Description:
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Overall Number of Participants Analyzed 1 1 2 7 51 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
  50.0%
0
   0.0%
3
   5.9%
1
  10.0%
3.Secondary Outcome
Title Maximum Change in QTcF
Hide Description Maximum change in QTcF from baseline by dose level
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who received at least a portion of a dose of TRC253 with a baseline ECG and at least 1 on study ECG.
Arm/Group Title 40 mg TRC253/Daily 80 mg TRC253/Daily 160 mg TRC253/Daily 240 mg TRC253/Daily 280 mg TRC253/Daily 320 mg TRC253/Daily
Hide Arm/Group Description:
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Overall Number of Participants Analyzed 1 0 1 7 50 8
Mean (Full Range)
Unit of Measure: msec
9
(9 to 9)
22
(22 to 22)
44.62
(32 to 64)
37.56
(0 to 77)
42.63
(5 to 93)
4.Secondary Outcome
Title Percent Change From Baseline in Standard Uptake Value (SUV) to Assess TRC253 Receptor Occupancy
Hide Description 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.
Time Frame 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
TRC253 4 week FDHT-PET response mean SUV based on the 5 hottest lesions (uncorrected)
Arm/Group Title 40 mg TRC253/Daily 80 mg TRC253/Daily 160 mg TRC253/Daily 240 mg TRC253/Daily 280 mg TRC253/Daily 320 mg TRC253/Daily
Hide Arm/Group Description:
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Overall Number of Participants Analyzed 0 0 1 2 1 2
Mean (Full Range)
Unit of Measure: Percent Change from Baseline
-34.1
(-34.1 to -34.1)
-2.81
(-37.32 to 31.71)
27.78
(27.78 to 27.78)
-45.88
(-57.32 to -34.43)
5.Secondary Outcome
Title Median Time to Progression by Dose Level
Hide Description Preliminary anti-tumor effects of TRC253 as assessed by median time to progression by Prostate Cancer Working Group 3 (PCWG3) criteria by dose level
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
In order to be eligible for efficacy analysis patients must have had a baseline CT scan and at least 1 on study CT scan.
Arm/Group Title 40 mg TRC253/Daily Dose Levels Combined 80 mg TRC253/Daily Dose Levels Combined 160 mg TRC253/Daily Dose Levels Combined 240 mg TRC253/Daily 280 mg TRC253/Daily 320 mg TRC253/Daily
Hide Arm/Group Description:
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Overall Number of Participants Analyzed 1 1 2 7 44 8
Median (95% Confidence Interval)
Unit of Measure: months
8.7 [1] 
(NA to NA)
9.5 [1] 
(NA to NA)
4.8 [1] 
(NA to NA)
3.75 [2] 
(2.01 to NA)
4.64
(2.04 to 7.17)
12.20 [2] 
(1.91 to NA)
[1]
The upper and lower confidence level cannot be calculated due to the small sample size
[2]
The upper confidence level cannot be calculated due to the small sample size
6.Secondary Outcome
Title Number of Patients Who Achieved the Target Concentration of TRC253 at Steady State
Hide Description 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).
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who received at least 75% of planned continuous daily dosing after 28 days of daily dosing enrolled in part 1 of the study.
Arm/Group Title 40 mg TRC253/Daily 80 mg TRC253/Daily 160 mg TRC253/Daily 240 mg TRC253/Daily 280 mg TRC253/Daily 320 mg TRC253/Daily
Hide Arm/Group Description:
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Single-agent TRC253 to be administered as oral capsules once daily.
Overall Number of Participants Analyzed 1 1 2 7 4 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
4
  57.1%
4
 100.0%
5
  83.3%
Time Frame 18 months
Adverse Event Reporting Description Duration of participation +28 days
 
Arm/Group Title 40 mg TRC253/Daily 80 mg TRC253/Daily 160 mg TRC253/Daily 240 mg TRC253/Daily 280 mg TRC253/Daily 320 mg TRC253/Daily
Hide Arm/Group Description Single-agent TRC253 to be administered as oral capsules once daily. Single-agent TRC253 to be administered as oral capsules once daily. Single-agent TRC253 to be administered as oral capsules once daily. Single-agent TRC253 to be administered as oral capsules once daily. Single-agent TRC253 to be administered as oral capsules once daily. Single-agent TRC253 to be administered as oral capsules once daily.
All-Cause Mortality
40 mg TRC253/Daily 80 mg TRC253/Daily 160 mg TRC253/Daily 240 mg TRC253/Daily 280 mg TRC253/Daily 320 mg TRC253/Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%)   0/2 (0.00%)   0/7 (0.00%)   1/51 (1.96%)   0/10 (0.00%) 
Hide Serious Adverse Events
40 mg TRC253/Daily 80 mg TRC253/Daily 160 mg TRC253/Daily 240 mg TRC253/Daily 280 mg TRC253/Daily 320 mg TRC253/Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   1/1 (100.00%)   1/2 (50.00%)   2/7 (28.57%)   13/51 (25.49%)   3/10 (30.00%) 
Blood and lymphatic system disorders             
Anaemia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/51 (0.00%)  0/10 (0.00%) 
Gastrointestinal disorders             
Abdominal Pain  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Rectal haemorrhage  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Vomiting  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
General disorders             
Disease progression  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Infections and infestations             
Pneumonia  1  0/1 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  0/51 (0.00%)  0/10 (0.00%) 
Device related infection  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/51 (0.00%)  0/10 (0.00%) 
Oesophageal candidiasis  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Oral candidiasis  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Pyelonephritis acute  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Urinary tract infection  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  2/51 (3.92%)  0/10 (0.00%) 
Injury, poisoning and procedural complications             
Hip fracture  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Overdose  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Metabolism and nutrition disorders             
Failure to thrive  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Hypercalcaemia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Hyperglycaemia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Musculoskeletal and connective tissue disorders             
Neck Pain  1  0/1 (0.00%)  1/1 (100.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  0/10 (0.00%) 
Osteonecrosis  1  0/1 (0.00%)  1/1 (100.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  0/10 (0.00%) 
Musculoskeletal pain  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Back pain  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Arthralgia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Bone pain  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Meningeal neoplasm  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Nervous system disorders             
Spinal cord compression  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  2/51 (3.92%)  0/10 (0.00%) 
Renal and urinary disorders             
Acute kidney injury  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Urinary tract obstruction  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Epistaxis  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/51 (0.00%)  0/10 (0.00%) 
Dyspnoea  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Surgical and medical procedures             
Intramedullary rod insertion  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Vascular disorders             
Hypotension  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
1
Term from vocabulary, MedDRA (14.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
40 mg TRC253/Daily 80 mg TRC253/Daily 160 mg TRC253/Daily 240 mg TRC253/Daily 280 mg TRC253/Daily 320 mg TRC253/Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/1 (100.00%)   1/1 (100.00%)   2/2 (100.00%)   7/7 (100.00%)   48/51 (94.12%)   10/10 (100.00%) 
Blood and lymphatic system disorders             
Anaemia  1  0/1 (0.00%)  1/1 (100.00%)  1/2 (50.00%)  2/7 (28.57%)  8/51 (15.69%)  2/10 (20.00%) 
Thrombocytopenia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  2/51 (3.92%)  0/10 (0.00%) 
Splenic infarction  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Cardiac disorders             
Bradycardia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Sinus tachycardia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Tachycardia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Coronary artery occlusion  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Ear and labyrinth disorders             
Vertigo  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/51 (0.00%)  0/10 (0.00%) 
Tinnitus  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Endocrine disorders             
Hypothyroidism  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Eye disorders             
Diplopia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/51 (0.00%)  0/10 (0.00%) 
Eye discharge  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/51 (0.00%)  0/10 (0.00%) 
Eyelid ptosis  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/51 (0.00%)  0/10 (0.00%) 
Corneal neovascularisation  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Eye swelling  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Vitreous haemorrhage  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Gastrointestinal disorders             
Constipation  1  0/1 (0.00%)  1/1 (100.00%)  0/2 (0.00%)  1/7 (14.29%)  8/51 (15.69%)  4/10 (40.00%) 
Gingival bleeding  1  0/1 (0.00%)  1/1 (100.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  0/10 (0.00%) 
Vomiting  1  0/1 (0.00%)  1/1 (100.00%)  1/2 (50.00%)  2/7 (28.57%)  6/51 (11.76%)  3/10 (30.00%) 
Abdominal pain  1  0/1 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  6/51 (11.76%)  2/10 (20.00%) 
Nausea  1  0/1 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  1/7 (14.29%)  9/51 (17.65%)  4/10 (40.00%) 
Ascites  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/51 (0.00%)  0/10 (0.00%) 
Diarrhoea  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  2/7 (28.57%)  10/51 (19.61%)  1/10 (10.00%) 
Eructation  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/51 (0.00%)  0/10 (0.00%) 
Haematochezia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/51 (0.00%)  0/10 (0.00%) 
Abdominal discomfort  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Abdominal distension  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Dry mouth  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Flatulence  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Gastrooesophageal reflux disease  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
General disorders             
Fatigue  1  0/1 (0.00%)  1/1 (100.00%)  1/2 (50.00%)  1/7 (14.29%)  9/51 (17.65%)  6/10 (60.00%) 
Pyrexia  1  0/1 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  3/51 (5.88%)  1/10 (10.00%) 
Temperature intolerance  1  0/1 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  0/51 (0.00%)  0/10 (0.00%) 
Facial pain  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/51 (0.00%)  0/10 (0.00%) 
Pain  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  3/7 (42.86%)  0/51 (0.00%)  0/10 (0.00%) 
Asthenia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  3/51 (5.88%)  2/10 (20.00%) 
Chills  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Gait disturbance  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Oedema peripheral  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  4/51 (7.84%)  2/10 (20.00%) 
Non-cardiac chest pain  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  1/10 (10.00%) 
Infections and infestations             
Lung infection  1  0/1 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Acute sinusitis  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/51 (0.00%)  0/10 (0.00%) 
Device related infection  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/51 (0.00%)  0/10 (0.00%) 
Genital infection fungal  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/51 (0.00%)  0/10 (0.00%) 
Oral herpes  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/51 (0.00%)  0/10 (0.00%) 
Abscess  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Bronchitis  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Pyelonephritis acute  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Sinusitis  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  2/51 (3.92%)  0/10 (0.00%) 
Upper respiratory tract infection  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  6/51 (11.76%)  0/10 (0.00%) 
Urinary tract infection  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  5/51 (9.80%)  0/10 (0.00%) 
Staphylococcal infection  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Nasopharyngitis  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Injury, poisoning and procedural complications             
Fractured sacrum  1  0/1 (0.00%)  1/1 (100.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  0/10 (0.00%) 
Clavicle fracture  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/51 (0.00%)  0/10 (0.00%) 
Fall  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  3/51 (5.88%)  1/10 (10.00%) 
Hip Fracture  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Rib fracture  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  2/51 (3.92%)  0/10 (0.00%) 
Investigations             
Blood alkaline phosphatase increased  1  0/1 (0.00%)  1/1 (100.00%)  1/2 (50.00%)  1/7 (14.29%)  3/51 (5.88%)  0/10 (0.00%) 
Electrocardiogram QT prolonged  1  0/1 (0.00%)  1/1 (100.00%)  1/2 (50.00%)  3/7 (42.86%)  14/51 (27.45%)  5/10 (50.00%) 
Platelet count decreased  1  0/1 (0.00%)  1/1 (100.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Weight decreased  1  0/1 (0.00%)  1/1 (100.00%)  1/2 (50.00%)  0/7 (0.00%)  5/51 (9.80%)  0/10 (0.00%) 
White blood cell count decreased  1  0/1 (0.00%)  1/1 (100.00%)  0/2 (0.00%)  0/7 (0.00%)  2/51 (3.92%)  0/10 (0.00%) 
White blood cell count increased  1  0/1 (0.00%)  1/1 (100.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  0/10 (0.00%) 
Lipase increased  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/51 (0.00%)  1/10 (10.00%) 
Lymphocyte count decreased  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/51 (0.00%)  0/10 (0.00%) 
Alanine aminotransferase increased  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Aspartate aminotransferase increased  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  2/51 (3.92%)  2/10 (20.00%) 
Blood creatinine increased  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  5/51 (9.80%)  1/10 (10.00%) 
Blood thyroid stimulating hormone increased  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Blood amylase increased  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Lipase increased  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Metabolism and nutrition disorders             
Decreased appetite  1  0/1 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  7/51 (13.73%)  2/10 (20.00%) 
Hypertriglyceridaemia  1  0/1 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  1/7 (14.29%)  0/51 (0.00%)  0/10 (0.00%) 
Hypoalbuminaemia  1  0/1 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  1/7 (14.29%)  0/51 (0.00%)  0/10 (0.00%) 
Hyponatraemia  1  0/1 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  1/7 (14.29%)  2/51 (3.92%)  0/10 (0.00%) 
Acidosis  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/51 (0.00%)  0/10 (0.00%) 
Hypophosphataemia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  3/51 (5.88%)  0/10 (0.00%) 
Dehydration  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  3/51 (5.88%)  0/10 (0.00%) 
Hyperkalaemia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Hypocalcaemia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  2/51 (3.92%)  0/10 (0.00%) 
Hyperglycaemia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Hypermagnesaemia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Hypokalaemia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Hypomagnesaemia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/51 (0.00%)  1/10 (10.00%) 
Musculoskeletal and connective tissue disorders             
Musculoskeletal pain  1  1/1 (100.00%)  0/1 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  3/51 (5.88%)  1/10 (10.00%) 
Pain in extremity  1  1/1 (100.00%)  1/1 (100.00%)  0/2 (0.00%)  0/7 (0.00%)  4/51 (7.84%)  4/10 (40.00%) 
Arthralgia  1  0/1 (0.00%)  1/1 (100.00%)  1/2 (50.00%)  2/7 (28.57%)  5/51 (9.80%)  1/10 (10.00%) 
Bone Pain  1  0/1 (0.00%)  1/1 (100.00%)  0/2 (0.00%)  2/7 (28.57%)  3/51 (5.88%)  1/10 (10.00%) 
Muscular weakness  1  0/1 (0.00%)  1/1 (100.00%)  0/2 (0.00%)  1/7 (14.29%)  4/51 (7.84%)  0/10 (0.00%) 
Pathological fracture  1  0/1 (0.00%)  1/1 (100.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  0/10 (0.00%) 
Back pain  1  0/1 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  3/7 (42.86%)  8/51 (15.69%)  5/10 (50.00%) 
Flank pain  1  0/1 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  2/51 (3.92%)  0/10 (0.00%) 
Neck pain  1  0/1 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Muscle spasms  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  1/51 (1.96%)  1/10 (10.00%) 
Pain in jaw  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/51 (0.00%)  0/10 (0.00%) 
Joint stiffness  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Musculoskeletal chest pain  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  5/51 (9.80%)  0/10 (0.00%) 
Myalgia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  3/51 (5.88%)  1/10 (10.00%) 
Pelvic Pain  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Cancer pain  1  0/1 (0.00%)  1/1 (100.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  0/10 (0.00%) 
Lipoma  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Squamous cell carcinoma of skin  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Nervous system disorders             
Neuropathy peripheral  1  0/1 (0.00%)  1/1 (100.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Spinal cord compression  1  0/1 (0.00%)  1/1 (100.00%)  0/2 (0.00%)  1/7 (14.29%)  1/51 (1.96%)  0/10 (0.00%) 
Dizziness  1  0/1 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  6/51 (11.76%)  2/10 (20.00%) 
Extrapyramidal disorder  1  0/1 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  0/51 (0.00%)  0/10 (0.00%) 
Headache  1  0/1 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  2/51 (3.92%)  1/10 (10.00%) 
Burning sensation  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/51 (0.00%)  0/10 (0.00%) 
Hypoaesthesia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  2/7 (28.57%)  0/51 (0.00%)  0/10 (0.00%) 
Cerebrovascular accident  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Dysgeusia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  3/51 (5.88%)  0/10 (0.00%) 
Hypogeusia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Paraesthesia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  2/51 (3.92%)  0/10 (0.00%) 
Paraparesis  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Presyncope  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  2/51 (3.92%)  0/10 (0.00%) 
Sciatica  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Syncope  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
VIIth nerve paralysis  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Restless legs syndrome  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Psychiatric disorders             
Anxiety  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Insomnia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  3/51 (5.88%)  0/10 (0.00%) 
Agitation  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Renal and urinary disorders             
Haematuria  1  1/1 (100.00%)  0/1 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  3/51 (5.88%)  0/10 (0.00%) 
Urinary incontinence  1  0/1 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Nocturia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/51 (0.00%)  0/10 (0.00%) 
Proteinuria  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/51 (0.00%)  0/10 (0.00%) 
Acute kidney injury  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Hydronephrosis  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Micturition urgency  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Neurogenic Bladder  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Pollakiuria  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  1/10 (10.00%) 
Urinary retention  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Vesicocutaneous fistula  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Dysuria  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Reproductive system and breast disorders             
Gynaecomastia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Epistaxis  1  0/1 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  2/7 (28.57%)  0/51 (0.00%)  1/10 (10.00%) 
Oropharyngeal pain  1  0/1 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Pneumonia  1  0/1 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  1/51 (1.96%)  1/10 (10.00%) 
Dyspnoea  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  2/51 (3.92%)  2/10 (20.00%) 
Productive cough  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  2/7 (28.57%)  0/51 (0.00%)  1/10 (10.00%) 
Respiratory disorder  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  1/51 (1.96%)  0/10 (0.00%) 
Cough  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  6/51 (11.76%)  2/10 (20.00%) 
Hiccups  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Hypoxia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Pleural effusion  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  2/51 (3.92%)  1/10 (10.00%) 
Pneumonia aspiration  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Rhinorrhoea  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Sinus congestion  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Haemoptysis  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Skin and subcutaneous tissue disorders             
Dry skin  1  0/1 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  3/51 (5.88%)  0/10 (0.00%) 
Pain of skin  1  0/1 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  0/51 (0.00%)  0/10 (0.00%) 
Rash pruritic  1  0/1 (0.00%)  0/1 (0.00%)  1/2 (50.00%)  0/7 (0.00%)  0/51 (0.00%)  0/10 (0.00%) 
Alopecia  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Ecchymosis  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Night sweats  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Onychomadesis  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Petechiae  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Rash  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  2/51 (3.92%)  1/10 (10.00%) 
Dermatitis acneiform  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Dermatitis contact  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Dermatitis  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Hyperhidrosis  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Rash maculo-papular  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Urticaria  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  0/51 (0.00%)  1/10 (10.00%) 
Vascular disorders             
Hot flush  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/7 (14.29%)  0/51 (0.00%)  0/10 (0.00%) 
Deep vein thrombosis  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Hypertension  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  3/51 (5.88%)  0/10 (0.00%) 
Hypotension  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  5/51 (9.80%)  1/10 (10.00%) 
Subclavian artery thrombosis  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  1/51 (1.96%)  0/10 (0.00%) 
Orthostatic hypotension  1  0/1 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/7 (0.00%)  2/51 (3.92%)  1/10 (10.00%) 
1
Term from vocabulary, MedDRA (14.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Charles Theuer, MD PhD
Organization: Tracon Pharmaceuticals Inc.
Phone: 8585500780
EMail: ctheuer@traconpharma.com
Layout table for additonal information
Responsible Party: Tracon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02987829    
Other Study ID Numbers: 253PC101
First Submitted: December 5, 2016
First Posted: December 9, 2016
Results First Submitted: March 1, 2021
Results First Posted: April 23, 2021
Last Update Posted: April 23, 2021