Trial Outcomes & Findings for Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer (NCT NCT02212197)
NCT ID: NCT02212197
Last Updated: 2017-04-25
Results Overview
Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, Cmax was derived for Doses 1 and 3 of the investigational medicinal product (IMP).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
84 days
Results posted on
2017-04-25
Participant Flow
Participant milestones
| Measure |
CAM2032 3.75 mg
Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
|
CAM2032 7.5 mg
Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
|
Eligard 7.5 mg
Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
15
|
17
|
|
Overall Study
COMPLETED
|
18
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
CAM2032 3.75 mg
Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
|
CAM2032 7.5 mg
Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
|
Eligard 7.5 mg
Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
|
|---|---|---|---|
|
Overall Study
Need for radiotherapy
|
1
|
0
|
0
|
Baseline Characteristics
Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer
Baseline characteristics by cohort
| Measure |
CAM2032 3.75 mg
n=19 Participants
Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
|
CAM2032 7.5 mg
n=15 Participants
Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
|
Eligard 7.5 mg
n=17 Participants
Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Age, Continuous
|
69.7 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
71.9 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
70.9 years
STANDARD_DEVIATION 7 • n=5 Participants
|
70.8 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
20 participants
n=4 Participants
|
|
Region of Enrollment
Finland
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
8 participants
n=5 Participants
|
31 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 84 daysPopulation: The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.
Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, Cmax was derived for Doses 1 and 3 of the investigational medicinal product (IMP).
Outcome measures
| Measure |
CAM2032 3.75 mg
n=15 Participants
Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
|
CAM2032 7.5 mg
n=15 Participants
Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
|
Eligard 7.5 mg
n=17 Participants
Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
|
|---|---|---|---|
|
Observed Maximum Serum Leuprolide Concentration (Cmax) for Dose 1 and Dose 3
Dose 1
|
6.14 ng/mL
Geometric Coefficient of Variation 41.1
|
9.66 ng/mL
Geometric Coefficient of Variation 31.5
|
13.6 ng/mL
Geometric Coefficient of Variation 54.7
|
|
Observed Maximum Serum Leuprolide Concentration (Cmax) for Dose 1 and Dose 3
Dose 3
|
5.36 ng/mL
Geometric Coefficient of Variation 33.3
|
11.3 ng/mL
Geometric Coefficient of Variation 36.8
|
12.1 ng/mL
Geometric Coefficient of Variation 47.3
|
PRIMARY outcome
Timeframe: Days 0-28 and Days 56-84Population: The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.
Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, t1/2 was derived for Doses 1 and 3 of the IMP.
Outcome measures
| Measure |
CAM2032 3.75 mg
n=15 Participants
Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
|
CAM2032 7.5 mg
n=15 Participants
Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
|
Eligard 7.5 mg
n=17 Participants
Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
|
|---|---|---|---|
|
Apparent Terminal Half-life (t½) for Dose 1 and Dose 3
Dose 1
|
205 hour
Standard Deviation 113
|
231 hour
Standard Deviation 142
|
743 hour
Standard Deviation 1677
|
|
Apparent Terminal Half-life (t½) for Dose 1 and Dose 3
Dose 3
|
299 hour
Standard Deviation 277
|
434 hour
Standard Deviation 867
|
378 hour
Standard Deviation 570
|
PRIMARY outcome
Timeframe: Days 0-28 and Days 56-84 (0-672 hours after Doses 1 and 3)Population: The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.
Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, AUCtau was derived for Doses 1 and 3 of the IMP.
Outcome measures
| Measure |
CAM2032 3.75 mg
n=15 Participants
Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
|
CAM2032 7.5 mg
n=15 Participants
Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
|
Eligard 7.5 mg
n=17 Participants
Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
|
|---|---|---|---|
|
Area Under the Serum Concentration-time Curve (AUC) Over the Dosing Interval (AUCtau) for Dose 1 and Dose 3
Dose 1
|
329 h*ng/mL
Geometric Coefficient of Variation 37.6
|
622 h*ng/mL
Geometric Coefficient of Variation 45.2
|
397 h*ng/mL
Geometric Coefficient of Variation 45.3
|
|
Area Under the Serum Concentration-time Curve (AUC) Over the Dosing Interval (AUCtau) for Dose 1 and Dose 3
Dose 3
|
343 h*ng/mL
Geometric Coefficient of Variation 24.7
|
757 h*ng/mL
Geometric Coefficient of Variation 53.4
|
460 h*ng/mL
Geometric Coefficient of Variation 62.2
|
SECONDARY outcome
Timeframe: Days 56-126Population: The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.
The pharmacodynamic (PD) effects of leuprolide were assessed by measuring serum testosterone during the trial. Time to testosterone recovery after last dose of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126.
Outcome measures
| Measure |
CAM2032 3.75 mg
n=15 Participants
Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
|
CAM2032 7.5 mg
n=15 Participants
Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
|
Eligard 7.5 mg
n=17 Participants
Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
|
|---|---|---|---|
|
Time (Days) to Testosterone Recovery After Dose 3
|
46.2 days
Standard Deviation 13.6
|
52.3 days
Standard Deviation 20.6
|
65 days
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: Days 0-126Population: The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.
The PD effects of leuprolide were assessed by measuring serum testosterone concentrations during the trial. The following PD variable was analyzed: The profiles of testosterone concentration (ng/dL) following injections of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126.
Outcome measures
| Measure |
CAM2032 3.75 mg
n=15 Participants
Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
|
CAM2032 7.5 mg
n=15 Participants
Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
|
Eligard 7.5 mg
n=17 Participants
Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
|
|---|---|---|---|
|
Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP)
Day 0 (predose)
|
443 ng/dL
Interval 369.0 to 546.0
|
321 ng/dL
Interval 269.0 to 439.0
|
350 ng/dL
Interval 240.0 to 465.0
|
|
Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP)
Day 28 (predose)
|
20.9 ng/dL
Interval 18.3 to 47.0
|
24.5 ng/dL
Interval 16.1 to 210.0
|
18.1 ng/dL
Interval 11.1 to 28.1
|
|
Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP)
Day 56 (predose)
|
14.6 ng/dL
Interval 10.7 to 19.3
|
13.8 ng/dL
Interval 7.8 to 22.0
|
12 ng/dL
Interval 9.29 to 15.0
|
|
Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP)
Day 84
|
14.8 ng/dL
Interval 9.17 to 27.6
|
10.6 ng/dL
Interval 7.5 to 18.8
|
12.4 ng/dL
Interval 9.92 to 13.8
|
|
Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP)
Day 126
|
423 ng/dL
Interval 258.0 to 526.0
|
278 ng/dL
Interval 124.0 to 470.0
|
85.8 ng/dL
Interval 16.0 to 280.0
|
SECONDARY outcome
Timeframe: Days 0-126Population: The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.
The PD effects of leuprolide were assessed by measuring serum PSA concentrations during the trial. The following PD variable was analyzed: PSA (ng/mL) response to IMP. Blood samples for analyses of plasma PSA concentrations were collected at Screening and on Days 0 to 126.
Outcome measures
| Measure |
CAM2032 3.75 mg
n=15 Participants
Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
|
CAM2032 7.5 mg
n=15 Participants
Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
|
Eligard 7.5 mg
n=17 Participants
Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
|
|---|---|---|---|
|
Mean Prostate Specific Antigen (PSA) Concentration
Day 0 (predose)
|
14.9 ng/mL
Interval 5.8 to 85.4
|
18.8 ng/mL
Interval 9.6 to 93.5
|
14.6 ng/mL
Interval 4.7 to 32.9
|
|
Mean Prostate Specific Antigen (PSA) Concentration
Day 28 (predose)
|
9 ng/mL
Interval 2.8 to 19.0
|
8.3 ng/mL
Interval 5.9 to 31.5
|
4.6 ng/mL
Interval 2.3 to 8.0
|
|
Mean Prostate Specific Antigen (PSA) Concentration
Day 56 (predose)
|
3.6 ng/mL
Interval 1.1 to 8.4
|
5.8 ng/mL
Interval 1.1 to 11.2
|
2.1 ng/mL
Interval 0.8 to 4.1
|
|
Mean Prostate Specific Antigen (PSA) Concentration
Day 84
|
2.3 ng/mL
Interval 1.1 to 5.6
|
2.6 ng/mL
Interval 0.8 to 14.0
|
1.6 ng/mL
Interval 0.4 to 2.7
|
|
Mean Prostate Specific Antigen (PSA) Concentration
Day 126
|
4.7 ng/mL
Interval 2.9 to 19.9
|
3.1 ng/mL
Interval 1.5 to 19.1
|
1.6 ng/mL
Interval 0.5 to 3.8
|
Adverse Events
CAM2032 3.75 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
CAM2032 7.5 mg
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Eligard 7.5 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CAM2032 3.75 mg
n=19 participants at risk
Single subcutaneous buttock injections of CAM2032 3.75 mg on Days 0, 28 and 56.
|
CAM2032 7.5 mg
n=15 participants at risk
Single subcutaneous buttock injections of CAM2032 7.5 mg on Days 0, 28 and 56.
|
Eligard 7.5 mg
n=17 participants at risk
Single subcutaneous buttock injections of Eligard 7.5 mg on Days 0, 28 and 56.
|
|---|---|---|---|
|
Psychiatric disorders
Disorientation
|
0.00%
0/19
|
6.7%
1/15 • Number of events 1
|
0.00%
0/17
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/19
|
6.7%
1/15 • Number of events 1
|
0.00%
0/17
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/19
|
6.7%
1/15 • Number of events 1
|
0.00%
0/17
|
Other adverse events
| Measure |
CAM2032 3.75 mg
n=19 participants at risk
Single subcutaneous buttock injections of CAM2032 3.75 mg on Days 0, 28 and 56.
|
CAM2032 7.5 mg
n=15 participants at risk
Single subcutaneous buttock injections of CAM2032 7.5 mg on Days 0, 28 and 56.
|
Eligard 7.5 mg
n=17 participants at risk
Single subcutaneous buttock injections of Eligard 7.5 mg on Days 0, 28 and 56.
|
|---|---|---|---|
|
Vascular disorders
Hot flush
|
42.1%
8/19 • Number of events 8
|
26.7%
4/15 • Number of events 4
|
29.4%
5/17 • Number of events 5
|
|
Vascular disorders
Hypertension
|
15.8%
3/19 • Number of events 3
|
6.7%
1/15 • Number of events 1
|
0.00%
0/17
|
|
Vascular disorders
Haematoma
|
5.3%
1/19 • Number of events 1
|
0.00%
0/15
|
0.00%
0/17
|
|
General disorders
Pyrexia
|
0.00%
0/19
|
0.00%
0/15
|
11.8%
2/17 • Number of events 3
|
|
General disorders
Injection site erythema
|
0.00%
0/19
|
6.7%
1/15 • Number of events 2
|
0.00%
0/17
|
|
General disorders
Fatigue
|
0.00%
0/19
|
0.00%
0/15
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Injection site nodule
|
0.00%
0/19
|
6.7%
1/15 • Number of events 1
|
0.00%
0/17
|
|
General disorders
Oedema peripheral
|
0.00%
0/19
|
0.00%
0/15
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/19
|
6.7%
1/15 • Number of events 1
|
0.00%
0/17
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/19
|
0.00%
0/15
|
11.8%
2/17 • Number of events 2
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/19
|
6.7%
1/15 • Number of events 1
|
0.00%
0/17
|
|
Reproductive system and breast disorders
Prostatic pain
|
5.3%
1/19 • Number of events 1
|
0.00%
0/15
|
0.00%
0/17
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/19
|
6.7%
1/15 • Number of events 1
|
0.00%
0/17
|
|
Reproductive system and breast disorders
Genital pain
|
0.00%
0/19
|
0.00%
0/15
|
5.9%
1/17 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
15.8%
3/19 • Number of events 3
|
0.00%
0/15
|
5.9%
1/17 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.3%
1/19 • Number of events 1
|
0.00%
0/15
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/19
|
6.7%
1/15 • Number of events 1
|
0.00%
0/17
|
|
Investigations
Blood creatine phosphokinase increased
|
5.3%
1/19 • Number of events 1
|
0.00%
0/15
|
5.9%
1/17 • Number of events 1
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.3%
1/19 • Number of events 1
|
0.00%
0/15
|
5.9%
1/17 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
1/19 • Number of events 1
|
0.00%
0/15
|
0.00%
0/17
|
|
Investigations
Blood glucose increased
|
5.3%
1/19 • Number of events 1
|
0.00%
0/15
|
0.00%
0/17
|
|
Investigations
C-reactive protein increased
|
0.00%
0/19
|
0.00%
0/15
|
5.9%
1/17 • Number of events 1
|
|
Cardiac disorders
Angina pectoris
|
5.3%
1/19 • Number of events 1
|
0.00%
0/15
|
0.00%
0/17
|
|
Cardiac disorders
Arrhytmia
|
5.3%
1/19 • Number of events 1
|
0.00%
0/15
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/19
|
6.7%
1/15 • Number of events 2
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.3%
1/19 • Number of events 1
|
0.00%
0/15
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/19
|
0.00%
0/15
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/19
|
6.7%
1/15 • Number of events 2
|
17.6%
3/17 • Number of events 6
|
|
Nervous system disorders
Sciatica
|
5.3%
1/19 • Number of events 1
|
0.00%
0/15
|
0.00%
0/17
|
|
Nervous system disorders
Syncope
|
0.00%
0/19
|
0.00%
0/15
|
5.9%
1/17 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.00%
0/19
|
6.7%
1/15 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/19
|
0.00%
0/15
|
5.9%
1/17 • Number of events 1
|
|
Eye disorders
Eye pain
|
0.00%
0/19
|
6.7%
1/15 • Number of events 1
|
0.00%
0/17
|
|
Gastrointestinal disorders
Nausea
|
21.1%
4/19 • Number of events 5
|
0.00%
0/15
|
0.00%
0/17
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • Number of events 1
|
0.00%
0/15
|
0.00%
0/17
|
|
Gastrointestinal disorders
Inguinal hernia
|
5.3%
1/19 • Number of events 1
|
0.00%
0/15
|
0.00%
0/17
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/19
|
6.7%
1/15 • Number of events 1
|
0.00%
0/17
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/19
|
13.3%
2/15 • Number of events 2
|
11.8%
2/17 • Number of events 2
|
|
Renal and urinary disorders
Haematuria
|
5.3%
1/19 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
0.00%
0/17
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/19
|
13.3%
2/15 • Number of events 2
|
0.00%
0/17
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
5.3%
1/19 • Number of events 1
|
0.00%
0/15
|
0.00%
0/17
|
|
Renal and urinary disorders
Micturition
|
5.3%
1/19 • Number of events 1
|
0.00%
0/15
|
0.00%
0/17
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/19
|
0.00%
0/15
|
5.9%
1/17 • Number of events 1
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/19
|
0.00%
0/15
|
5.9%
1/17 • Number of events 1
|
|
Renal and urinary disorders
Urethral pain
|
0.00%
0/19
|
6.7%
1/15 • Number of events 1
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.3%
1/19 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/19
|
20.0%
3/15 • Number of events 4
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
1/19 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
11.8%
2/17 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.3%
1/19 • Number of events 2
|
0.00%
0/15
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/19
|
13.3%
2/15 • Number of events 2
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
0.00%
0/19
|
6.7%
1/15 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
5.3%
1/19 • Number of events 1
|
0.00%
0/15
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
1/19 • Number of events 1
|
0.00%
0/15
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.3%
1/19 • Number of events 1
|
0.00%
0/15
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/19
|
0.00%
0/15
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/19
|
0.00%
0/15
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/19
|
6.7%
1/15 • Number of events 1
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/19
|
0.00%
0/15
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.3%
1/19 • Number of events 1
|
0.00%
0/15
|
0.00%
0/17
|
|
Infections and infestations
Influenza
|
15.8%
3/19 • Number of events 6
|
20.0%
3/15 • Number of events 3
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Abscess
|
5.3%
1/19 • Number of events 1
|
0.00%
0/15
|
0.00%
0/17
|
|
Infections and infestations
Bronchitis
|
5.3%
1/19 • Number of events 1
|
0.00%
0/15
|
0.00%
0/17
|
|
Infections and infestations
Gastroenteritis
|
5.3%
1/19 • Number of events 1
|
0.00%
0/15
|
0.00%
0/17
|
|
Infections and infestations
Localised infection
|
5.3%
1/19 • Number of events 1
|
0.00%
0/15
|
0.00%
0/17
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
1/19 • Number of events 1
|
0.00%
0/15
|
0.00%
0/17
|
|
Infections and infestations
Sinusitis
|
5.3%
1/19 • Number of events 1
|
0.00%
0/15
|
0.00%
0/17
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/19
|
0.00%
0/15
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/19
|
0.00%
0/15
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/19
|
6.7%
1/15 • Number of events 1
|
0.00%
0/17
|
|
Investigations
Blood urine
|
0.00%
0/19
|
0.00%
0/15
|
5.9%
1/17 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60