Trial Outcomes & Findings for Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Nonvalvular Atrial Fibrillation (NVAF) (NCT NCT02072434)
NCT ID: NCT02072434
Last Updated: 2019-03-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2199 participants
Primary outcome timeframe
Randomization to end of follow-up (within 2 years)
Results posted on
2019-03-15
Participant Flow
Participant milestones
| Measure |
Edoxaban
Participants randomized to receive Edoxaban
|
Warfarin
Participants randomized to receive Warfarin
|
|---|---|---|
|
Overall Study
STARTED
|
1095
|
1104
|
|
Overall Study
Intent to Treat Analysis Set
|
1095
|
1104
|
|
Overall Study
Received Study Drug
|
1067
|
1082
|
|
Overall Study
Safety Analysis Set
|
1067
|
1082
|
|
Overall Study
COMPLETED
|
1041
|
1014
|
|
Overall Study
NOT COMPLETED
|
54
|
90
|
Reasons for withdrawal
| Measure |
Edoxaban
Participants randomized to receive Edoxaban
|
Warfarin
Participants randomized to receive Warfarin
|
|---|---|---|
|
Overall Study
Protocol Violation
|
10
|
9
|
|
Overall Study
Physician Decision
|
5
|
10
|
|
Overall Study
Adverse event, serious fatal
|
1
|
6
|
|
Overall Study
Adverse Event
|
7
|
6
|
|
Overall Study
Withdrawal by Subject
|
17
|
29
|
|
Overall Study
Other
|
14
|
29
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Nonvalvular Atrial Fibrillation (NVAF)
Baseline characteristics by cohort
| Measure |
Edoxaban
n=1095 Participants
Participants randomized to receive Edoxaban
|
Warfarin
n=1104 Participants
Participants randomized to receive Warfarin
|
Total
n=2199 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 10.34 • n=99 Participants
|
64.2 years
STANDARD_DEVIATION 10.75 • n=107 Participants
|
64.2 years
STANDARD_DEVIATION 10.54 • n=206 Participants
|
|
Age, Customized
Age, Categorical · <75 years
|
923 Participants
n=99 Participants
|
917 Participants
n=107 Participants
|
1840 Participants
n=206 Participants
|
|
Age, Customized
Age, Categorical · ≥75 years
|
172 Participants
n=99 Participants
|
187 Participants
n=107 Participants
|
359 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
374 Participants
n=99 Participants
|
382 Participants
n=107 Participants
|
756 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
721 Participants
n=99 Participants
|
722 Participants
n=107 Participants
|
1443 Participants
n=206 Participants
|
|
Region of Enrollment
Romania
|
68 participants
n=99 Participants
|
54 participants
n=107 Participants
|
122 participants
n=206 Participants
|
|
Region of Enrollment
Hungary
|
89 participants
n=99 Participants
|
90 participants
n=107 Participants
|
179 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=99 Participants
|
49 participants
n=107 Participants
|
95 participants
n=206 Participants
|
|
Region of Enrollment
Czechia
|
86 participants
n=99 Participants
|
87 participants
n=107 Participants
|
173 participants
n=206 Participants
|
|
Region of Enrollment
Ukraine
|
206 participants
n=99 Participants
|
224 participants
n=107 Participants
|
430 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
76 participants
n=99 Participants
|
83 participants
n=107 Participants
|
159 participants
n=206 Participants
|
|
Region of Enrollment
Russia
|
110 participants
n=99 Participants
|
106 participants
n=107 Participants
|
216 participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
73 participants
n=99 Participants
|
69 participants
n=107 Participants
|
142 participants
n=206 Participants
|
|
Region of Enrollment
Austria
|
19 participants
n=99 Participants
|
13 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
24 participants
n=99 Participants
|
23 participants
n=107 Participants
|
47 participants
n=206 Participants
|
|
Region of Enrollment
Sweden
|
7 participants
n=99 Participants
|
7 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Region of Enrollment
Belgium
|
19 participants
n=99 Participants
|
22 participants
n=107 Participants
|
41 participants
n=206 Participants
|
|
Region of Enrollment
Denmark
|
26 participants
n=99 Participants
|
31 participants
n=107 Participants
|
57 participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
21 participants
n=99 Participants
|
33 participants
n=107 Participants
|
54 participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
34 participants
n=99 Participants
|
35 participants
n=107 Participants
|
69 participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
39 participants
n=99 Participants
|
43 participants
n=107 Participants
|
82 participants
n=206 Participants
|
|
Region of Enrollment
Bulgaria
|
70 participants
n=99 Participants
|
55 participants
n=107 Participants
|
125 participants
n=206 Participants
|
|
Region of Enrollment
France
|
26 participants
n=99 Participants
|
13 participants
n=107 Participants
|
39 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
56 participants
n=99 Participants
|
67 participants
n=107 Participants
|
123 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Randomization to end of follow-up (within 2 years)Population: This outcome was assessed in the Intent-to-Treat (ITT) Analysis Set.
Outcome measures
| Measure |
Edoxaban
n=1095 Participants
Participants randomized to receive Edoxaban
|
Warfarin
n=1104 Participants
Participants randomized to receive Warfarin
|
|---|---|---|
|
Percentage of Participants With Composite Endpoint of Stroke, Systemic Embolic Stroke (SEE), Myocardial Infarction (MI) and Cardiovascular (CV) Mortality From Randomization to End of Follow up
|
0.5 Percentage of participants
|
1 Percentage of participants
|
PRIMARY outcome
Timeframe: During treatment period (within 2 years)Population: This outcome was assessed in the Safety Analysis Set.
Outcome measures
| Measure |
Edoxaban
n=1067 Participants
Participants randomized to receive Edoxaban
|
Warfarin
n=1082 Participants
Participants randomized to receive Warfarin
|
|---|---|---|
|
Percentage of Participants With Composite Endpoints of Major and Clinically-relevant Non-major (CRNM) Bleeding
|
1.5 Percentage of participants
|
1 Percentage of participants
|
SECONDARY outcome
Timeframe: From randomization to the end of follow-up (within 2 years)Population: This outcome was assessed in the ITT Analysis Set.
Outcome measures
| Measure |
Edoxaban
n=1095 Participants
Participants randomized to receive Edoxaban
|
Warfarin
n=1104 Participants
Participants randomized to receive Warfarin
|
|---|---|---|
|
Percentage of Participants With Composite Endpoints of Stroke, SEE, MI, CV Mortality, and Major Bleeding
|
0.7 Percentage of participants
|
1.4 Percentage of participants
|
Adverse Events
Edoxaban
Serious events: 85 serious events
Other events: 53 other events
Deaths: 1 deaths
Warfarin
Serious events: 83 serious events
Other events: 53 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Edoxaban
n=1067 participants at risk
Participants randomized to receive Edoxaban
|
Warfarin
n=1082 participants at risk
Participants randomized to receive Warfarin
|
|---|---|---|
|
Vascular disorders
Hypertensive crisis
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Vascular disorders
Deep vein thrombosis
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Vascular disorders
Haemodynamic instability
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Vascular disorders
Peripheral embolism
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Vascular disorders
Thrombophlebitis
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
General disorders
Asthenia
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
General disorders
Death
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
General disorders
Drug effect increased
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
General disorders
Injection site bruising
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Investigations
International normalised ratio increased
|
0.37%
4/1067 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.92%
10/1082 • Number of events 10 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Investigations
Liver function test abnormal
|
0.19%
2/1067 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Investigations
Blood urine present
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Investigations
Coagulation test abnormal
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Investigations
International normalised ratio fluctuation
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Investigations
Oxygen saturation decreased
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
20/1067 • Number of events 20 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
1.3%
14/1082 • Number of events 14 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Cardiac disorders
Cardiac failure
|
0.28%
3/1067 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.55%
6/1082 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.47%
5/1067 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.28%
3/1082 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Cardiac disorders
Atrial flutter
|
0.28%
3/1067 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.18%
2/1082 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.19%
2/1067 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.18%
2/1082 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.18%
2/1082 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Cardiac disorders
Bradycardia
|
0.19%
2/1067 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Cardiac disorders
Cardiac failure acute
|
0.28%
3/1067 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.19%
2/1067 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Cardiac disorders
Myocardial infarction
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.18%
2/1082 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Cardiac disorders
Palpitations
|
0.19%
2/1067 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.18%
2/1082 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.19%
2/1067 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.18%
2/1082 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Cardiac disorders
Arrhythmia
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Cardiac disorders
Chordae tendinae rupture
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Cardiac disorders
Torsade de pointes
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.19%
2/1067 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.19%
2/1067 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal cyst
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Pulomonary haemorrhage
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.19%
2/1067 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Blood and lymphatic system disorders
Hypocoagulable state
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.18%
2/1082 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Nervous system disorders
Syncope
|
0.19%
2/1067 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Nervous system disorders
Headache
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Nervous system disorders
Presyncope
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.18%
2/1082 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Gastrointestinal disorders
Diarrhea
|
0.19%
2/1067 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Gastrointestinal disorders
Haematochezia
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Gastrointestinal disorders
Spigelian hernia
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Renal and urinary disorders
Renal failure acute
|
0.28%
3/1067 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.18%
2/1082 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Renal and urinary disorders
Haematuria
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.18%
2/1082 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Endocrine disorders
Hyperadrenocorticism
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Infections and infestations
Pneumonia
|
0.37%
4/1067 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.37%
4/1082 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Infections and infestations
Erysipelas
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Infections and infestations
Arthritis bacterial
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Infections and infestations
Clostridium difficile infection
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Infections and infestations
Endocarditis bacterial
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Infections and infestations
Gastroenteritis
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Infections and infestations
Infective aneurysm
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/1067 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.09%
1/1082 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Infections and infestations
Lung infection
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Infections and infestations
Sepsis
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
|
Infections and infestations
Urosepsis
|
0.09%
1/1067 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
0.00%
0/1082 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
Other adverse events
| Measure |
Edoxaban
n=1067 participants at risk
Participants randomized to receive Edoxaban
|
Warfarin
n=1082 participants at risk
Participants randomized to receive Warfarin
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
53/1067 • Number of events 53 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
4.9%
53/1082 • Number of events 53 • Treatment-emergent adverse events (TEAEs) were defined as events that started on or after the first dose of study drug or started prior to but then became worse after the first dose of study drug through 30 days after the last dose of study drug (within 2 years).
This table includes counts of participants in the Safety Analysis Set. Participants who experienced more than one episode of an adverse event are counted only once within a preferred term. Participants who experienced more than one adverse event within a system organ class are counted once for each preferred term, but only once for the system organ class.
|
Additional Information
Daiichi Sankyo US Contact for Clinical Trial Results
Daiichi Sankyo, Inc.
Phone: 1-908-992-6400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60