Trial Outcomes & Findings for Determination of Safe and Effective Dose of Romiplostim (AMG 531) in Subjects With Myelodysplastic Syndrome (MDS)Receiving Hypomethylating Agents (NCT NCT00321711)
NCT ID: NCT00321711
Last Updated: 2018-10-17
Results Overview
Occurrence of a clinically significant thrombocytopenic event within the participant, defined as any platelet count obtained from day 15 of cycle 1 through the end of the interim follow-up visit that was less than 50 x 10\^9/L or receipt of platelet transfusions at any time through the interim follow-up visit.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
69 participants
Primary outcome timeframe
Treatment period (up to 20 weeks)
Results posted on
2018-10-17
Participant Flow
Participants in Part A were enrolled from 9 November 2006 through 31 August 2007; participants in Part B were enrolled from 26 March 2008 through 3 November 2008. Participants who enrolled in Part A were not eligible for enrollment in Part B.
Participant milestones
| Measure |
Romiplostim (AMG 531) Placebo Plus Azacitidine
Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m\^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
|
Romiplostim (AMG 531) 500 mcg Plus Azacitidine
500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m\^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
|
Romiplostim (AMG 531) 750 mcg Plus Azacitidine
750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m\^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
|
Romiplostim (AMG 531) Placebo Plus Decitabine
Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m\^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
|
Romiplostim (AMG 531) 750 mcg Plus Decitabine
750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m\^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
|
|---|---|---|---|---|---|
|
Part A
STARTED
|
13
|
13
|
14
|
0
|
0
|
|
Part A
COMPLETED
|
8
|
3
|
3
|
0
|
0
|
|
Part A
NOT COMPLETED
|
5
|
10
|
11
|
0
|
0
|
|
Part B
STARTED
|
0
|
0
|
0
|
14
|
15
|
|
Part B
COMPLETED
|
0
|
0
|
0
|
8
|
10
|
|
Part B
NOT COMPLETED
|
0
|
0
|
0
|
6
|
5
|
Reasons for withdrawal
| Measure |
Romiplostim (AMG 531) Placebo Plus Azacitidine
Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m\^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
|
Romiplostim (AMG 531) 500 mcg Plus Azacitidine
500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m\^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
|
Romiplostim (AMG 531) 750 mcg Plus Azacitidine
750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m\^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
|
Romiplostim (AMG 531) Placebo Plus Decitabine
Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m\^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
|
Romiplostim (AMG 531) 750 mcg Plus Decitabine
750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m\^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
|
|---|---|---|---|---|---|
|
Part A
Adverse Event
|
3
|
3
|
2
|
0
|
0
|
|
Part A
Withdrawal by Subject
|
1
|
1
|
1
|
0
|
0
|
|
Part A
Disease progression
|
0
|
1
|
0
|
0
|
0
|
|
Part A
Requirement for alternative therapy
|
0
|
2
|
1
|
0
|
0
|
|
Part A
Physician Decision
|
0
|
1
|
3
|
0
|
0
|
|
Part A
Other
|
1
|
2
|
3
|
0
|
0
|
|
Part A
Protocol deviation
|
0
|
0
|
1
|
0
|
0
|
|
Part B
Noncompliance
|
0
|
0
|
0
|
0
|
1
|
|
Part B
Adverse Event
|
0
|
0
|
0
|
2
|
1
|
|
Part B
Disease progression
|
0
|
0
|
0
|
1
|
0
|
|
Part B
Physician Decision
|
0
|
0
|
0
|
1
|
2
|
|
Part B
Death
|
0
|
0
|
0
|
2
|
1
|
Baseline Characteristics
Determination of Safe and Effective Dose of Romiplostim (AMG 531) in Subjects With Myelodysplastic Syndrome (MDS)Receiving Hypomethylating Agents
Baseline characteristics by cohort
| Measure |
Romiplostim (AMG 531) Placebo Plus Azacitidine
n=13 Participants
Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m\^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
|
Romiplostim (AMG 531) 500 mcg Plus Azacitidine
n=13 Participants
500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m\^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
|
Romiplostim (AMG 531) 750 mcg Plus Azacitidine
n=14 Participants
750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m\^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
|
Romiplostim (AMG 531) Placebo Plus Decitabine
n=14 Participants
Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m\^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
|
Romiplostim (AMG 531) 750 mcg Plus Decitabine
n=15 Participants
750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m\^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
67.3 Years
n=5 Participants
|
71.9 Years
n=7 Participants
|
71.4 Years
n=5 Participants
|
70.5 Years
n=4 Participants
|
68.2 Years
n=21 Participants
|
69.8 Years
n=10 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
26 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
43 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
57 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Treatment period (up to 20 weeks)Population: Full Analysis Set, composed of all randomized participants
Occurrence of a clinically significant thrombocytopenic event within the participant, defined as any platelet count obtained from day 15 of cycle 1 through the end of the interim follow-up visit that was less than 50 x 10\^9/L or receipt of platelet transfusions at any time through the interim follow-up visit.
Outcome measures
| Measure |
Romiplostim (AMG 531) Placebo Plus Azacitidine
n=13 Participants
Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m\^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
|
Romiplostim (AMG 531) 500 mcg Plus Azacitidine
n=13 Participants
500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m\^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
|
Romiplostim (AMG 531) 750 mcg Plus Azacitidine
n=14 Participants
750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m\^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
|
Romiplostim (AMG 531) Placebo Plus Decitabine
n=14 Participants
Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m\^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
|
Romiplostim (AMG 531) 750 mcg Plus Decitabine
n=15 Participants
750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m\^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
|
|---|---|---|---|---|---|
|
Occurrence of a Clinically Significant Thrombocytopenic Event
|
11 Participants
|
8 Participants
|
10 Participants
|
11 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Treatment period (up to 20 weeks)Population: Full Analysis Set, composed of all randomized participants
Occurrence of hypomethylating agent dose reduction and delay due to thrombocytopenia
Outcome measures
| Measure |
Romiplostim (AMG 531) Placebo Plus Azacitidine
n=13 Participants
Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m\^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
|
Romiplostim (AMG 531) 500 mcg Plus Azacitidine
n=13 Participants
500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m\^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
|
Romiplostim (AMG 531) 750 mcg Plus Azacitidine
n=14 Participants
750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m\^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
|
Romiplostim (AMG 531) Placebo Plus Decitabine
n=14 Participants
Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m\^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
|
Romiplostim (AMG 531) 750 mcg Plus Decitabine
n=15 Participants
750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m\^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
|
|---|---|---|---|---|---|
|
Hypomethylating Agent Dose Reduction and Delay Due to Thrombocytopenia
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Treatment period (up to 20 weeks)Population: Full Analysis Set, composed of all randomized participants
CR = decrease in bone marrow blast (≤5%) and improvement in peripheral blood counts (Hgb ≥ 11 g/dL, platelets ≥ 100x10\^9/L, neutrophils ≥ 1x10\^9/L, peripheral blasts=0%). PR = improvement in peripheral blood counts plus a decrease in bone marrow blasts ≥50% but not ≤5, or decrease in International Prognostic Scoring System score.
Outcome measures
| Measure |
Romiplostim (AMG 531) Placebo Plus Azacitidine
n=13 Participants
Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m\^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
|
Romiplostim (AMG 531) 500 mcg Plus Azacitidine
n=13 Participants
500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m\^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
|
Romiplostim (AMG 531) 750 mcg Plus Azacitidine
n=14 Participants
750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m\^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
|
Romiplostim (AMG 531) Placebo Plus Decitabine
n=14 Participants
Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m\^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
|
Romiplostim (AMG 531) 750 mcg Plus Decitabine
n=15 Participants
750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m\^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
|
|---|---|---|---|---|---|
|
Achieving an Overall Response (Complete or Partial Response, CR or PR) at the End of the Treatment Period
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Study day 1 through the interim follow-up visit (up to 20 weeks)Population: Full Analysis Set, composed of all randomized participants
Occurrence of one or more platelet transfusions from study day 1 through the interim follow-up visit (16 weeks)
Outcome measures
| Measure |
Romiplostim (AMG 531) Placebo Plus Azacitidine
n=13 Participants
Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m\^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
|
Romiplostim (AMG 531) 500 mcg Plus Azacitidine
n=13 Participants
500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m\^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
|
Romiplostim (AMG 531) 750 mcg Plus Azacitidine
n=14 Participants
750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m\^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
|
Romiplostim (AMG 531) Placebo Plus Decitabine
n=14 Participants
Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m\^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
|
Romiplostim (AMG 531) 750 mcg Plus Decitabine
n=15 Participants
750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m\^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
|
|---|---|---|---|---|---|
|
Platelet Transfusion
|
9 Participants
|
6 Participants
|
5 Participants
|
8 Participants
|
7 Participants
|
Adverse Events
Part A Placebo
Serious events: 9 serious events
Other events: 11 other events
Deaths: 0 deaths
Part A Romiplostim 500 µg
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Part A Romiplostim 750 µg
Serious events: 10 serious events
Other events: 14 other events
Deaths: 0 deaths
Part B Placebo
Serious events: 8 serious events
Other events: 14 other events
Deaths: 0 deaths
Part B Romiplostim 750 µg
Serious events: 8 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A Placebo
n=13 participants at risk
|
Part A Romiplostim 500 µg
n=13 participants at risk
|
Part A Romiplostim 750 µg
n=14 participants at risk
|
Part B Placebo
n=14 participants at risk
|
Part B Romiplostim 750 µg
n=15 participants at risk
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
23.1%
3/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
21.4%
3/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
26.7%
4/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Caecitis
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Asthenia
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Chest pain
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Inflammation
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Pain
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Pyrexia
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.3%
2/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Appendicitis
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Diverticulitis
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Endocarditis
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Implant site infection
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Infection
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pneumonia
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.3%
2/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pneumonia fungal
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Sepsis
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.3%
2/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Convulsion
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Dysarthria
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Syncope
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Disorientation
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Haematoma
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Hypotension
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Other adverse events
| Measure |
Part A Placebo
n=13 participants at risk
|
Part A Romiplostim 500 µg
n=13 participants at risk
|
Part A Romiplostim 750 µg
n=14 participants at risk
|
Part B Placebo
n=14 participants at risk
|
Part B Romiplostim 750 µg
n=15 participants at risk
|
|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
30.8%
4/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
38.5%
5/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
30.8%
4/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
26.7%
4/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
38.5%
5/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
23.1%
3/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
21.4%
3/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
20.0%
3/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Anaemia
|
23.1%
3/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
28.6%
4/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.3%
2/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Anaemia haemolytic autoimmune
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Bone marrow disorder
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.3%
2/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Neutropenia
|
30.8%
4/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
30.8%
4/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
64.3%
9/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
26.7%
4/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
30.8%
4/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
21.4%
3/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.3%
2/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Thrombocytopenic purpura
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Eye pain
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Constipation
|
38.5%
5/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
53.8%
7/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
50.0%
7/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
35.7%
5/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
26.7%
4/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
30.8%
4/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
42.9%
6/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
35.7%
5/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
20.0%
3/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal oedema
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gingival bleeding
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gingival erythema
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gingival pain
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.3%
2/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Nausea
|
46.2%
6/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
30.8%
4/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
42.9%
6/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
42.9%
6/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
33.3%
5/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Tooth socket haemorrhage
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Toothache
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.3%
2/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Asthenia
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.3%
2/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Catheter site inflammation
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Catheter thrombosis
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Chest pain
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Chills
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.3%
2/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Cyst
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Fatigue
|
38.5%
5/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
30.8%
4/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
21.4%
3/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.3%
2/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Gait disturbance
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Infusion site haemorrhage
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Injection site discomfort
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Injection site erythema
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
21.4%
3/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Injection site haematoma
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Injection site haemorrhage
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Injection site irritation
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Injection site pain
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
28.6%
4/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Injection site pruritus
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Injection site rash
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Injection site reaction
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Injection site swelling
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Malaise
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Mucosal inflammation
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Oedema peripheral
|
30.8%
4/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
21.4%
3/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
20.0%
3/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Pain
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Pyrexia
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
21.4%
3/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
28.6%
4/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
20.0%
3/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Reproductive system and breast disorders
Scrotal erythema
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Candidiasis
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Cystitis
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Furuncle
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Infection
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Localised infection
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
20.0%
3/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Oral candidiasis
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Reproductive system and breast disorders
Scrotal swelling
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Oral herpes
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Parotitis
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Perirectal abscess
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pharyngeal abscess
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pharyngitis
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Sepsis
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
28.6%
4/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.3%
2/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Contusion
|
23.1%
3/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
23.1%
3/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.3%
2/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
21.4%
3/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Blood magnesium decreased
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Blood pressure increased
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Cardiac murmur
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Heart sounds abnormal
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Platelet count decreased
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Pulmonary arterial pressure increased
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Reticulin increased
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Investigations
Weight decreased
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
23.1%
3/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
35.7%
5/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.3%
2/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Gout
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.3%
2/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Iron overload
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
21.4%
3/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
21.4%
3/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle swelling
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
35.7%
5/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
20.0%
3/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Cerebral ischaemia
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
28.6%
4/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
21.4%
3/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.3%
2/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Dysgeusia
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Headache
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.3%
2/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Hypoaesthesia
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Tremor
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
13.3%
2/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Depression
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Insomnia
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
28.6%
4/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
26.7%
4/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Pollakiuria
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Renal failure
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Reproductive system and breast disorders
Penile discharge
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
21.4%
3/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
23.1%
3/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
30.8%
4/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
15.4%
2/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
21.4%
3/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin nodule
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.7%
1/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Vasculitic rash
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Surgical and medical procedures
Breast lump removal
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Hot flush
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Hypertension
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.1%
1/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
28.6%
4/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
14.3%
2/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Orthostatic hypotension
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Pallor
|
0.00%
0/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
7.7%
1/13 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/14 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/15 • Up to 20 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER