Trial Outcomes & Findings for Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients (NCT NCT00215657)
NCT ID: NCT00215657
Last Updated: 2011-05-20
Results Overview
The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases \>3x ULN and ALT increases \>3x ULN with concurrently increased bilirubin \>1.5 ULN.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
131 participants
Primary outcome timeframe
3 years
Results posted on
2011-05-20
Participant Flow
Participants who responded to degarelix in FE200486 CS07 (NCT00818623) were eligible to enroll into this extension study with the intention of continuing treatment until degarelix became commercially available or until the study was discontinued. Participants received the same dose of degarelix as they received in FE200486 CS07.
180 participants started the main study CS07 and 172 participants received degarelix treatment (intention-to-treat population). Of these, 131 participants were recruited into the extension study CS07A
Participant milestones
| Measure |
Degarelix 120mg (20mg/mL)
Degarelix 120 mg (20 mg/mL)
|
Degarelix 120mg (40mg/mL)
Degarelix 120 mg (40 mg/mL)
|
Degarelix 160mg (40mg/mL)
Degarelix 160 mg (40 mg/mL)
|
Degarelix 200mg (40mg/mL)
Degarelix 200 mg (40 mg/mL)
|
Degarelix 200mg (60mg/mL)
Degarelix 200 mg (60 mg/mL)
|
Degarelix 240mg (40mg/mL)
Degarelix 240 mg (40 mg/mL)
|
Degarelix 240mg (60mg/mL)
Degarelix 240 mg (60 mg/mL)
|
Degarelix 320mg (60mg/mL)
Degarelix 320 mg (60 mg/mL)
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
12
|
13
|
24
|
27
|
24
|
27
|
27
|
|
Overall Study
Intention-to-treat Population
|
25
|
12
|
12
|
24
|
24
|
24
|
24
|
27
|
|
Overall Study
Started FE200486 CS07A
|
20
|
6
|
7
|
24
|
17
|
20
|
14
|
23
|
|
Overall Study
COMPLETED
|
4
|
1
|
2
|
6
|
4
|
4
|
4
|
11
|
|
Overall Study
NOT COMPLETED
|
22
|
11
|
11
|
18
|
23
|
20
|
23
|
16
|
Reasons for withdrawal
| Measure |
Degarelix 120mg (20mg/mL)
Degarelix 120 mg (20 mg/mL)
|
Degarelix 120mg (40mg/mL)
Degarelix 120 mg (40 mg/mL)
|
Degarelix 160mg (40mg/mL)
Degarelix 160 mg (40 mg/mL)
|
Degarelix 200mg (40mg/mL)
Degarelix 200 mg (40 mg/mL)
|
Degarelix 200mg (60mg/mL)
Degarelix 200 mg (60 mg/mL)
|
Degarelix 240mg (40mg/mL)
Degarelix 240 mg (40 mg/mL)
|
Degarelix 240mg (60mg/mL)
Degarelix 240 mg (60 mg/mL)
|
Degarelix 320mg (60mg/mL)
Degarelix 320 mg (60 mg/mL)
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
1
|
3
|
0
|
3
|
1
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
3
|
1
|
6
|
1
|
10
|
3
|
|
Overall Study
Insuff prostate specific antigen resp
|
3
|
2
|
2
|
2
|
1
|
2
|
3
|
2
|
|
Overall Study
Insufficient testosterone response
|
5
|
4
|
1
|
12
|
8
|
12
|
4
|
7
|
|
Overall Study
Other
|
3
|
1
|
2
|
3
|
5
|
4
|
6
|
1
|
Baseline Characteristics
Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients
Baseline characteristics by cohort
| Measure |
Degarelix 120mg (20mg/mL)
n=25 Participants
Degarelix 120 mg (20 mg/mL)
|
Degarelix 120mg (40mg/mL)
n=12 Participants
Degarelix 120 mg (40 mg/mL)
|
Degarelix 160mg (40mg/mL)
n=12 Participants
Degarelix 160 mg (40 mg/mL)
|
Degarelix 200mg (40mg/mL)
n=24 Participants
Degarelix 200 mg (40 mg/mL)
|
Degarelix 200mg (60mg/mL)
n=24 Participants
Degarelix 200 mg (60 mg/mL)
|
Degarelix 240mg (40mg/mL)
n=24 Participants
Degarelix 240 mg (40 mg/mL)
|
Degarelix 240mg (60mg/mL)
n=24 Participants
Degarelix 240 mg (60 mg/mL)
|
Degarelix 320mg (60mg/mL)
n=27 Participants
Degarelix 320 mg (60 mg/mL)
|
Total
n=172 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
29 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
21 Participants
n=24 Participants
|
143 Participants
n=42 Participants
|
|
Age Continuous
|
70.0 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
73.8 years
STANDARD_DEVIATION 3.97 • n=7 Participants
|
70.1 years
STANDARD_DEVIATION 8.08 • n=5 Participants
|
74.3 years
STANDARD_DEVIATION 6.48 • n=4 Participants
|
71.5 years
STANDARD_DEVIATION 8.27 • n=21 Participants
|
73.1 years
STANDARD_DEVIATION 5.96 • n=10 Participants
|
71.7 years
STANDARD_DEVIATION 9.54 • n=115 Participants
|
71.1 years
STANDARD_DEVIATION 6.87 • n=24 Participants
|
71.9 years
STANDARD_DEVIATION 7.83 • n=42 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
27 Participants
n=24 Participants
|
172 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
25 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
24 participants
n=4 Participants
|
24 participants
n=21 Participants
|
24 participants
n=10 Participants
|
24 participants
n=115 Participants
|
27 participants
n=24 Participants
|
172 participants
n=42 Participants
|
|
Curative intent
Yes
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
1 participants
n=24 Participants
|
7 participants
n=42 Participants
|
|
Curative intent
No
|
25 participants
n=5 Participants
|
12 participants
n=7 Participants
|
10 participants
n=5 Participants
|
21 participants
n=4 Participants
|
23 participants
n=21 Participants
|
24 participants
n=10 Participants
|
24 participants
n=115 Participants
|
26 participants
n=24 Participants
|
165 participants
n=42 Participants
|
|
Gleason score
2-4
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
5 participants
n=21 Participants
|
2 participants
n=10 Participants
|
5 participants
n=115 Participants
|
12 participants
n=24 Participants
|
31 participants
n=42 Participants
|
|
Gleason score
5-6
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
5 participants
n=5 Participants
|
6 participants
n=4 Participants
|
3 participants
n=21 Participants
|
6 participants
n=10 Participants
|
6 participants
n=115 Participants
|
6 participants
n=24 Participants
|
43 participants
n=42 Participants
|
|
Gleason score
7-10
|
17 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
17 participants
n=4 Participants
|
16 participants
n=21 Participants
|
16 participants
n=10 Participants
|
13 participants
n=115 Participants
|
9 participants
n=24 Participants
|
98 participants
n=42 Participants
|
|
Stage of prostate cancer
Localized
|
10 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
1 participants
n=21 Participants
|
6 participants
n=10 Participants
|
8 participants
n=115 Participants
|
14 participants
n=24 Participants
|
46 participants
n=42 Participants
|
|
Stage of prostate cancer
Locally advanced
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
14 participants
n=4 Participants
|
8 participants
n=21 Participants
|
10 participants
n=10 Participants
|
5 participants
n=115 Participants
|
9 participants
n=24 Participants
|
63 participants
n=42 Participants
|
|
Stage of prostate cancer
Metastatic
|
9 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
6 participants
n=4 Participants
|
12 participants
n=21 Participants
|
6 participants
n=10 Participants
|
10 participants
n=115 Participants
|
2 participants
n=24 Participants
|
52 participants
n=42 Participants
|
|
Stage of prostate cancer
Not classifiable
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
2 participants
n=10 Participants
|
1 participants
n=115 Participants
|
2 participants
n=24 Participants
|
11 participants
n=42 Participants
|
|
Body mass index
|
26.2 kilogram per square meter
STANDARD_DEVIATION 2.97 • n=5 Participants
|
26.6 kilogram per square meter
STANDARD_DEVIATION 4.58 • n=7 Participants
|
26.3 kilogram per square meter
STANDARD_DEVIATION 3.74 • n=5 Participants
|
25.9 kilogram per square meter
STANDARD_DEVIATION 2.99 • n=4 Participants
|
24.5 kilogram per square meter
STANDARD_DEVIATION 2.92 • n=21 Participants
|
26.9 kilogram per square meter
STANDARD_DEVIATION 3.18 • n=10 Participants
|
24.8 kilogram per square meter
STANDARD_DEVIATION 2.72 • n=115 Participants
|
27.1 kilogram per square meter
STANDARD_DEVIATION 3.63 • n=24 Participants
|
26.0 kilogram per square meter
STANDARD_DEVIATION 3.32 • n=42 Participants
|
|
Time since prostate cancer diagnosis
|
83 days
STANDARD_DEVIATION 157 • n=5 Participants
|
66 days
STANDARD_DEVIATION 53 • n=7 Participants
|
222 days
STANDARD_DEVIATION 328 • n=5 Participants
|
146 days
STANDARD_DEVIATION 298 • n=4 Participants
|
252 days
STANDARD_DEVIATION 560 • n=21 Participants
|
303 days
STANDARD_DEVIATION 837 • n=10 Participants
|
121 days
STANDARD_DEVIATION 425 • n=115 Participants
|
47 days
STANDARD_DEVIATION 54 • n=24 Participants
|
156 days
STANDARD_DEVIATION 439 • n=42 Participants
|
|
Weight
|
77.8 kilogram
STANDARD_DEVIATION 12.4 • n=5 Participants
|
82.2 kilogram
STANDARD_DEVIATION 12.1 • n=7 Participants
|
80.7 kilogram
STANDARD_DEVIATION 11.8 • n=5 Participants
|
78.2 kilogram
STANDARD_DEVIATION 13.7 • n=4 Participants
|
74.2 kilogram
STANDARD_DEVIATION 9.88 • n=21 Participants
|
81.5 kilogram
STANDARD_DEVIATION 10.7 • n=10 Participants
|
73.5 kilogram
STANDARD_DEVIATION 9.55 • n=115 Participants
|
81.7 kilogram
STANDARD_DEVIATION 11.1 • n=24 Participants
|
78.4 kilogram
STANDARD_DEVIATION 11.6 • n=42 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: The data include patients from both the main study (FE200486 CS07) and the extension study FE200486 CS07A
The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases \>3x ULN and ALT increases \>3x ULN with concurrently increased bilirubin \>1.5 ULN.
Outcome measures
| Measure |
Degarelix 120mg (20mg/mL)
n=25 Participants
Degarelix 120 mg (20 mg/mL)
|
Degarelix 120mg (40mg/mL)
n=12 Participants
Degarelix 120 mg (40 mg/mL)
|
Degarelix 160mg (40mg/mL)
n=12 Participants
Degarelix 160 mg (40 mg/mL)
|
Degarelix 200mg (40mg/mL)
n=24 Participants
Degarelix 200 mg (40 mg/mL)
|
Degarelix 200mg (60mg/mL)
n=24 Participants
Degarelix 200 mg (60 mg/mL)
|
Degarelix 240mg (40mg/mL)
n=24 Participants
Degarelix 240 mg (40 mg/mL)
|
Degarelix 240mg (60mg/mL)
n=24 Participants
Degarelix 240 mg (60 mg/mL)
|
Degarelix 320mg (60mg/mL)
n=27 Participants
Degarelix 320 mg (60 mg/mL)
|
|---|---|---|---|---|---|---|---|---|
|
Liver Function Tests
Abnormal alanine aminotransferase (ALAT)
|
11 participants
|
4 participants
|
3 participants
|
7 participants
|
7 participants
|
7 participants
|
7 participants
|
9 participants
|
|
Liver Function Tests
Abnormal aspartate aminotransferase
|
9 participants
|
4 participants
|
2 participants
|
6 participants
|
8 participants
|
6 participants
|
6 participants
|
7 participants
|
|
Liver Function Tests
Abnormal bilirubin
|
4 participants
|
2 participants
|
0 participants
|
2 participants
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
|
Liver Function Tests
ALAT >3x ULN
|
4 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
1 participants
|
|
Liver Function Tests
ALAT >3x ULN, bilirubin >2x ULN
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: These data include patients from the main study (FE200486 CS07) and the extension study (FE200486 CS07A).
Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.
Outcome measures
| Measure |
Degarelix 120mg (20mg/mL)
n=25 Participants
Degarelix 120 mg (20 mg/mL)
|
Degarelix 120mg (40mg/mL)
n=12 Participants
Degarelix 120 mg (40 mg/mL)
|
Degarelix 160mg (40mg/mL)
n=12 Participants
Degarelix 160 mg (40 mg/mL)
|
Degarelix 200mg (40mg/mL)
n=24 Participants
Degarelix 200 mg (40 mg/mL)
|
Degarelix 200mg (60mg/mL)
n=24 Participants
Degarelix 200 mg (60 mg/mL)
|
Degarelix 240mg (40mg/mL)
n=24 Participants
Degarelix 240 mg (40 mg/mL)
|
Degarelix 240mg (60mg/mL)
n=24 Participants
Degarelix 240 mg (60 mg/mL)
|
Degarelix 320mg (60mg/mL)
n=27 Participants
Degarelix 320 mg (60 mg/mL)
|
|---|---|---|---|---|---|---|---|---|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Diastolic blood pressure <=50 and decrease >=15
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Diastolic blood pressure >=105 and increase >=15
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Systolic blood pressure <=90 and decrease >=20
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Systolic blood pressure >=180 and increase >=20
|
0 participants
|
0 participants
|
2 participants
|
5 participants
|
2 participants
|
6 participants
|
2 participants
|
3 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Heart rate <=50 and decrease >=15
|
1 participants
|
1 participants
|
2 participants
|
0 participants
|
2 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Heart rate >=120 and increase >=15
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Body weight decrease of >=7 percent
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Body weight increase of >=7 percent
|
4 participants
|
2 participants
|
3 participants
|
9 participants
|
3 participants
|
8 participants
|
7 participants
|
2 participants
|
Adverse Events
Degarelix 120mg (20mg/mL)
Serious events: 8 serious events
Other events: 18 other events
Deaths: 0 deaths
Degarelix 120mg (40mg/mL)
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Degarelix 160mg (40mg/mL)
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Degarelix 200mg (40mg/mL)
Serious events: 7 serious events
Other events: 24 other events
Deaths: 0 deaths
Degarelix 200mg (60mg/mL)
Serious events: 8 serious events
Other events: 17 other events
Deaths: 0 deaths
Degarelix 240mg (40mg/mL)
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Degarelix 240mg (60mg/mL)
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Degarelix 320mg (60mg/mL)
Serious events: 9 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Degarelix 120mg (20mg/mL)
Degarelix 120 mg (20 mg/mL)
|
Degarelix 120mg (40mg/mL)
Degarelix 120 mg (40 mg/mL)
|
Degarelix 160mg (40mg/mL)
Degarelix 160 mg (40 mg/mL)
|
Degarelix 200mg (40mg/mL)
Degarelix 200 mg (40 mg/mL)
|
Degarelix 200mg (60mg/mL)
Degarelix 200 mg (60 mg/mL)
|
Degarelix 240mg (40mg/mL)
Degarelix 240 mg (40 mg/mL)
|
Degarelix 240mg (60mg/mL)
Degarelix 240 mg (60 mg/mL)
|
Degarelix 320mg (60mg/mL)
Degarelix 320 mg (60 mg/mL)
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Cardiac disorders
Cardiac failure
|
4.0%
1/25 • Number of events 2
|
0.00%
0/12
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Gastrointestinal disorders
Inguinal hernia
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Mallory-weiss syndrome
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
General disorders
Disease progression
|
4.0%
1/25 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
General disorders
Pyrexia
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
General disorders
Asthenia
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Chest pain
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/27
|
|
Infections and infestations
Sepsis
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Infections and infestations
Urinary tract infection
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Infections and infestations
Bronchitis
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Infections and infestations
Erysipelas
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Infections and infestations
Infection
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Injury, poisoning and procedural complications
Caustic injury
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma stage iii
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
8.0%
2/25 • Number of events 2
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Nervous system disorders
Spinal cord compression
|
4.0%
1/25 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/27
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Vascular disorders
Thrombosis
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/27
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/27
|
|
General disorders
Condition aggravated
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
General disorders
Oedema
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
Gangrene
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Nervous system disorders
Areflexia
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Psychiatric disorders
Depression
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Surgical and medical procedures
Amputation revision
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Vascular disorders
Deep vein thrombosis
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Vascular disorders
Hypertension
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/27
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
Other adverse events
| Measure |
Degarelix 120mg (20mg/mL)
Degarelix 120 mg (20 mg/mL)
|
Degarelix 120mg (40mg/mL)
Degarelix 120 mg (40 mg/mL)
|
Degarelix 160mg (40mg/mL)
Degarelix 160 mg (40 mg/mL)
|
Degarelix 200mg (40mg/mL)
Degarelix 200 mg (40 mg/mL)
|
Degarelix 200mg (60mg/mL)
Degarelix 200 mg (60 mg/mL)
|
Degarelix 240mg (40mg/mL)
Degarelix 240 mg (40 mg/mL)
|
Degarelix 240mg (60mg/mL)
Degarelix 240 mg (60 mg/mL)
|
Degarelix 320mg (60mg/mL)
Degarelix 320 mg (60 mg/mL)
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
7.4%
2/27 • Number of events 2
|
|
Cardiac disorders
Arrhytmia
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/27
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Eye disorders
Cataract
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
|
Eye disorders
Glaucoma
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Constipation
|
8.0%
2/25 • Number of events 2
|
0.00%
0/12
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25
|
16.7%
2/12 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
12.5%
3/24 • Number of events 4
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/27
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
1/25 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
16.7%
4/24 • Number of events 4
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
4.2%
1/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/27
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Gastrointestinal disorders
Dyspepsia
|
4.0%
1/25 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
General disorders
Pyrexia
|
8.0%
2/25 • Number of events 2
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
8.3%
2/24 • Number of events 3
|
0.00%
0/24
|
8.3%
2/24 • Number of events 4
|
4.2%
1/24 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
20.8%
5/24 • Number of events 7
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Injection site erythema
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
8.3%
1/12 • Number of events 2
|
16.7%
4/24 • Number of events 4
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
General disorders
Injection site induration
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
4.2%
1/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/27
|
|
General disorders
Injection site swelling
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
General disorders
Injection site pain
|
4.0%
1/25 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
8.3%
2/24 • Number of events 2
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/27
|
|
General disorders
Oedema peripheral
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
8.3%
2/24 • Number of events 3
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
General disorders
Chills
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/27
|
|
General disorders
Feeling of body temperature change
|
8.0%
2/25 • Number of events 3
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
General disorders
Injection site pruritus
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
General disorders
Injection site reaction
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Infections and infestations
Urinary tract infection
|
12.0%
3/25 • Number of events 4
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
16.7%
4/24 • Number of events 6
|
8.3%
2/24 • Number of events 2
|
16.7%
4/24 • Number of events 5
|
16.7%
4/24 • Number of events 5
|
7.4%
2/27 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
1/25 • Number of events 1
|
25.0%
3/12 • Number of events 3
|
0.00%
0/12
|
16.7%
4/24 • Number of events 4
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
Influenza
|
4.0%
1/25 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
4.2%
1/24 • Number of events 2
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Infections and infestations
Injection site abscess
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
7.4%
2/27 • Number of events 2
|
|
Infections and infestations
Localised infection
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Infections and infestations
Nail infection
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Infections and infestations
Sinusitis
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/25
|
8.3%
1/12 • Number of events 4
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Investigations
Blood alkaline phosphatase increased
|
16.0%
4/25 • Number of events 5
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
8.3%
2/24 • Number of events 3
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Investigations
Alanine aminotranseferases increased
|
16.0%
4/25 • Number of events 5
|
8.3%
1/12 • Number of events 3
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.0%
3/25 • Number of events 4
|
8.3%
1/12 • Number of events 3
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 3
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Investigations
Weight decreased
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Investigations
Aspartate aminotransferase increased
|
12.0%
3/25 • Number of events 3
|
8.3%
1/12 • Number of events 3
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Investigations
Blood creatinine increased
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Investigations
Hepatic enzyme increased
|
4.0%
1/25 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/27
|
|
Investigations
White blood cells urine positive
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Investigations
Blood pressure increased
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
7.4%
2/27 • Number of events 3
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Investigations
Prostatic specific antigen increased
|
4.0%
1/25 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
1/25 • Number of events 1
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
20.8%
5/24 • Number of events 5
|
12.5%
3/24 • Number of events 4
|
12.5%
3/24 • Number of events 5
|
8.3%
2/24 • Number of events 2
|
3.7%
1/27 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.0%
2/25 • Number of events 2
|
0.00%
0/12
|
16.7%
2/12 • Number of events 2
|
8.3%
2/24 • Number of events 2
|
8.3%
2/24 • Number of events 2
|
4.2%
1/24 • Number of events 4
|
4.2%
1/24 • Number of events 1
|
7.4%
2/27 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
4.2%
1/24 • Number of events 2
|
12.5%
3/24 • Number of events 3
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
4.0%
1/25 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.0%
2/25 • Number of events 3
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
8.0%
2/25 • Number of events 2
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Nervous system disorders
Dizziness
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
12.5%
3/24 • Number of events 3
|
0.00%
0/24
|
0.00%
0/24
|
12.5%
3/24 • Number of events 3
|
0.00%
0/27
|
|
Nervous system disorders
Headache
|
4.0%
1/25 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
0.00%
0/12
|
16.7%
4/24 • Number of events 6
|
0.00%
0/24
|
12.5%
3/24 • Number of events 3
|
0.00%
0/24
|
0.00%
0/27
|
|
Nervous system disorders
Anosmia
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Psychiatric disorders
Insomnia
|
12.0%
3/25 • Number of events 3
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
16.7%
4/24 • Number of events 4
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
4.2%
1/24 • Number of events 2
|
0.00%
0/27
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/25
|
0.00%
0/12
|
16.7%
2/12 • Number of events 3
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
4.2%
1/24 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
12.5%
3/24 • Number of events 3
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
2/25 • Number of events 2
|
16.7%
2/12 • Number of events 2
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.0%
2/25 • Number of events 2
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
24.0%
6/25 • Number of events 6
|
16.7%
2/12 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
20.8%
5/24 • Number of events 6
|
20.8%
5/24 • Number of events 5
|
20.8%
5/24 • Number of events 5
|
8.3%
2/24 • Number of events 2
|
11.1%
3/27 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 2
|
4.2%
1/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 2
|
0.00%
0/27
|
|
Vascular disorders
Hot flush
|
16.0%
4/25 • Number of events 4
|
8.3%
1/12 • Number of events 1
|
25.0%
3/12 • Number of events 4
|
50.0%
12/24 • Number of events 14
|
25.0%
6/24 • Number of events 6
|
37.5%
9/24 • Number of events 9
|
16.7%
4/24 • Number of events 5
|
44.4%
12/27 • Number of events 13
|
|
Vascular disorders
Hypertension
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/27
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
General disorders
Chest pain
|
0.00%
0/25
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
8.3%
2/24 • Number of events 2
|
0.00%
0/24
|
0.00%
0/27
|
|
Infections and infestations
Cystitis
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/27
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/25
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.0%
1/25 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/25
|
8.3%
1/12 • Number of events 2
|
0.00%
0/12
|
4.2%
1/24 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Vascular disorders
Flushing
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/25
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/24
|
0.00%
0/27
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript.
- Publication restrictions are in place
Restriction type: OTHER