Trial Outcomes & Findings for A Study of the Safety and Efficacy of Hylan G-F 20 (Synvisc) in Patients With Symptomatic Osteoarthritis of the Knee (NCT NCT00131352)
NCT ID: NCT00131352
Last Updated: 2015-04-03
Results Overview
The change from baseline over the course of the 26-week initial treatment period using participants' assessment of pain. Mean scores were used for baseline (day 0) and for all visits up to week 26 (weeks 4, 8, 12, 18 and 26). The WOMAC Pain Subscale has a score range of 0-4, where 0=no pain and 4=extreme pain.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
253 participants
Primary outcome timeframe
Day 0, up to week 26
Results posted on
2015-04-03
Participant Flow
329 participants enrolled and 76 screening failures. One participant was randomised to the Synvisc group but received Saline in error; counted in the Saline group for safety analyses (Safety population) and in the Synvisc group for efficacy analyses (Intent-to-treat population) in both study periods.
Participant milestones
| Measure |
Synvisc
Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period. Participants from both treatment arms had the opportunity to receive an additional 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period.
|
Saline Control
Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline during the Initial Treatment Period.
|
|---|---|---|
|
Initial Treatment Period
STARTED
|
123
|
130
|
|
Initial Treatment Period
Intent to Treat Population
|
124
|
129
|
|
Initial Treatment Period
COMPLETED
|
114
|
118
|
|
Initial Treatment Period
NOT COMPLETED
|
9
|
12
|
|
Repeat Treatment Period
STARTED
|
160
|
0
|
|
Repeat Treatment Period
COMPLETED
|
158
|
0
|
|
Repeat Treatment Period
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Synvisc
Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period. Participants from both treatment arms had the opportunity to receive an additional 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period.
|
Saline Control
Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline during the Initial Treatment Period.
|
|---|---|---|
|
Initial Treatment Period
Adverse Event
|
1
|
3
|
|
Initial Treatment Period
Non-compliant
|
1
|
2
|
|
Initial Treatment Period
Withdrawal by Subject
|
1
|
1
|
|
Initial Treatment Period
Lack of Efficacy
|
6
|
4
|
|
Initial Treatment Period
Other
|
0
|
2
|
|
Repeat Treatment Period
Adverse Event
|
1
|
0
|
|
Repeat Treatment Period
Other
|
1
|
0
|
Baseline Characteristics
A Study of the Safety and Efficacy of Hylan G-F 20 (Synvisc) in Patients With Symptomatic Osteoarthritis of the Knee
Baseline characteristics by cohort
| Measure |
Synvisc
n=124 Participants
Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
|
Saline Control
n=129 Participants
Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
|
Total
n=253 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.6 years
STANDARD_DEVIATION 9.64 • n=99 Participants
|
62.5 years
STANDARD_DEVIATION 9.17 • n=107 Participants
|
63.0 years
STANDARD_DEVIATION 9.40 • n=206 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
180 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
118 participants
n=99 Participants
|
125 participants
n=107 Participants
|
243 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 participants
n=99 Participants
|
3 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 0, up to week 26Population: Intent-To-Treat (ITT) population which included all participants randomized to study treatment on Day 0.
The change from baseline over the course of the 26-week initial treatment period using participants' assessment of pain. Mean scores were used for baseline (day 0) and for all visits up to week 26 (weeks 4, 8, 12, 18 and 26). The WOMAC Pain Subscale has a score range of 0-4, where 0=no pain and 4=extreme pain.
Outcome measures
| Measure |
Synvisc
n=124 Participants
Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
|
Saline Control
n=129 Participants
Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
|
|---|---|---|
|
Change From Baseline in Knee Pain Over the Course of the 26-week Initial Treatment Period As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale
|
-0.84 units on a scale
Standard Error 0.060
|
-0.69 units on a scale
Standard Error 0.058
|
SECONDARY outcome
Timeframe: Day 0, Week 26Population: Intent-To-Treat (ITT) population.
The change from baseline to week 26 using participants' assessment of pain. The WOMAC Pain Subscale has a score range of 0-4, where 0=no pain and 4=extreme pain.
Outcome measures
| Measure |
Synvisc
n=124 Participants
Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
|
Saline Control
n=129 Participants
Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
|
|---|---|---|
|
Change From Baseline in Knee Pain at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale
|
-0.76 units on a scale
Standard Error 0.07
|
-0.58 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Week 26Population: Intent-To-Treat (ITT) population
Participants categorized the pain they felt while walking using the WOMAC LK 3.1) A1 (Walking Pain) Subscale. The scale rates pain as none, mild, moderate, severe and extreme.
Outcome measures
| Measure |
Synvisc
n=115 Participants
Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
|
Saline Control
n=117 Participants
Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
|
|---|---|---|
|
Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale
None
|
17 participants
|
13 participants
|
|
Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale
Mild
|
45 participants
|
39 participants
|
|
Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale
Moderate
|
41 participants
|
42 participants
|
|
Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale
Severe
|
11 participants
|
19 participants
|
|
Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale
Extreme
|
1 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Day 0, up to week 26Population: Intent-To-Treat (ITT) population.
The change from baseline over the course of the 26-week initial treatment period using participants' assessment of physical function. Mean scores were used for baseline (day 0) and for all visits up to week 26 (weeks 4, 8, 12, 18 and 26). The WOMAC Function Subscale has a score range of 0-4 to assess the degree of difficulty completing tasks within the past 48 hours, where 0=no difficulty and 4=extreme difficulty.
Outcome measures
| Measure |
Synvisc
n=124 Participants
Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
|
Saline Control
n=129 Participants
Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
|
|---|---|---|
|
Change From Baseline Over the Course of the 26-week Initial Treatment Period in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale
|
-0.66 units on a scale
Standard Error 0.061
|
-0.63 units on a scale
Standard Error 0.059
|
SECONDARY outcome
Timeframe: Day 0, Week 26Population: Intent-To-Treat (ITT) population.
The change from baseline to week 26 using participants' assessment of physical function. The WOMAC Function Subscale has a score range of 0-4 to assess the degree of difficulty completing tasks within the past 48 hours, where 0=no difficulty and 4=extreme difficulty.
Outcome measures
| Measure |
Synvisc
n=124 Participants
Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
|
Saline Control
n=129 Participants
Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
|
|---|---|---|
|
Change From Baseline at Week 26 in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale
|
-0.59 units on a scale
Standard Error 0.076
|
-0.48 units on a scale
Standard Error 0.074
|
SECONDARY outcome
Timeframe: Week 26Population: Intent-To-Treat (ITT) population
The Participant Global Assessment (PTGA) was used by participants to rate their osteoarthritis (OA). PTGA uses 5 scoring levels: Very well=0, Well=1, Fair=2, Poor=3, Very poor=4.
Outcome measures
| Measure |
Synvisc
n=115 Participants
Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
|
Saline Control
n=117 Participants
Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
|
|---|---|---|
|
Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26
Very Well
|
9 participants
|
2 participants
|
|
Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26
Well
|
33 participants
|
27 participants
|
|
Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26
Fair
|
50 participants
|
54 participants
|
|
Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26
Poor
|
21 participants
|
31 participants
|
|
Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26
Very Poor
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Week 26Population: Intent-To-Treat (ITT) population
The Blinded Clinical Observer gave a global assessment (COGA) of the target knee OA. COGA uses 5 scoring levels: Very well=0, Well=1, Fair=2, Poor=3, Very poor=4.
Outcome measures
| Measure |
Synvisc
n=115 Participants
Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
|
Saline Control
n=117 Participants
Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
|
|---|---|---|
|
Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26
Fair
|
38 participants
|
38 participants
|
|
Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26
Very Well
|
13 participants
|
8 participants
|
|
Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26
Well
|
37 participants
|
31 participants
|
|
Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26
Poor
|
22 participants
|
34 participants
|
|
Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26
Very Poor
|
5 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Week 26Population: Intent-To-Treat (ITT) population.
Participants were classified as a positive responder if at least one of the following two conditions were met: 1. A significant improvement in either the pain (WOMAC A) or physical function (WOMAC C) subscales, defined as both a ≥ 50% improvement from Baseline and an absolute change from Baseline of ≥ 20 normalised units (NU), OR 2. Improvement in at least 2 of 3 subscales - pain (WOMAC A), physical function (WOMAC C) or Participant Global Assessment (PTGA). Improvement for all three scales is defined as ≥ 20% improvement from Baseline and an absolute change from Baseline of ≥ 10 NU
Outcome measures
| Measure |
Synvisc
n=123 Participants
Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
|
Saline Control
n=129 Participants
Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
|
|---|---|---|
|
Participants Classified as Responders Per the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 26
Responder - meets OMERACT-OARSI criteria
|
73 participants
|
66 participants
|
|
Participants Classified as Responders Per the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 26
NonResponder -does not meet OMERACT-OARSI criteria
|
43 participants
|
52 participants
|
|
Participants Classified as Responders Per the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 26
NonResponder - Withdrew Before Study Completion
|
7 participants
|
11 participants
|
Adverse Events
Synvisc - Initial Treatment Period
Serious events: 5 serious events
Other events: 70 other events
Deaths: 0 deaths
Saline Control - Initial Treatment Period
Serious events: 3 serious events
Other events: 77 other events
Deaths: 0 deaths
Synvisc - Repeat Treatment Period
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Synvisc (From Saline Control) - Repeat Treatment Period
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Synvisc - Initial Treatment Period
n=123 participants at risk
Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period (up to week 26).
|
Saline Control - Initial Treatment Period
n=130 participants at risk
Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline during the initial treatment period.
|
Synvisc - Repeat Treatment Period
n=77 participants at risk
Participants from the Synvisc Initial Treatment Period had the opportunity to receive 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period (weeks 26-30).
|
Synvisc (From Saline Control) - Repeat Treatment Period
n=83 participants at risk
Participants from the Saline Control Initial Treatment Period had the opportunity to receive 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period (weeks 26-30).
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
1.2%
1/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Cardiac disorders
Bradycardia
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Cardiac disorders
Sinus arrest
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
General disorders
Hernia
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
General disorders
Non-cardiac chest pain
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
1.2%
1/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
1.2%
1/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Nervous system disorders
Radial nerve palsy
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
Other adverse events
| Measure |
Synvisc - Initial Treatment Period
n=123 participants at risk
Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period (up to week 26).
|
Saline Control - Initial Treatment Period
n=130 participants at risk
Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline during the initial treatment period.
|
Synvisc - Repeat Treatment Period
n=77 participants at risk
Participants from the Synvisc Initial Treatment Period had the opportunity to receive 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period (weeks 26-30).
|
Synvisc (From Saline Control) - Repeat Treatment Period
n=83 participants at risk
Participants from the Saline Control Initial Treatment Period had the opportunity to receive 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period (weeks 26-30).
|
|---|---|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Gastrointestinal disorders
Constipation
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Gastrointestinal disorders
Gastritis
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
1.5%
2/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Gastrointestinal disorders
Toothache
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
General disorders
Gait disturbance
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
General disorders
Hernia
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
1.3%
1/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
General disorders
Influenza like illness
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
General disorders
Injection site haematoma
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
1.3%
1/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
General disorders
Injection site pain
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
1.3%
1/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
2.4%
2/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
General disorders
Malaise
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
General disorders
Oedema peripheral
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
1.5%
2/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
General disorders
Pyrexia
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Infections and infestations
Bronchitis
|
1.6%
2/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
2.3%
3/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
2.6%
2/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Infections and infestations
Cellulitis
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Infections and infestations
Cystitis
|
1.6%
2/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Infections and infestations
Dental caries
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Infections and infestations
Erysipelas
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Infections and infestations
Herpes zoster
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Infections and infestations
Herpes zoster ophthalmic
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Infections and infestations
Infected insect bite
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
1.2%
1/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Infections and infestations
Influenza
|
3.3%
4/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
5.4%
7/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
1.2%
1/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
1.2%
1/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Infections and infestations
Mastitis
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
1.2%
1/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Infections and infestations
Nasopharyngitis
|
4.1%
5/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
5.4%
7/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Infections and infestations
Pharyngitis
|
2.4%
3/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Infections and infestations
Pharyngitis bacterial
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Infections and infestations
Respiratory tract infection
|
2.4%
3/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Infections and infestations
Sinusitis
|
1.6%
2/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Infections and infestations
Viral infection
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
2.4%
3/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
2.3%
3/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Investigations
Heart rate increased
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Investigations
Helicobacter pylori identification test positive
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.0%
32/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
23.1%
30/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
5.2%
4/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
2.4%
2/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
1.3%
1/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
1.2%
1/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
8/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
7.7%
10/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
1.3%
1/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
5.7%
7/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
5.4%
7/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
8.1%
10/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
10.0%
13/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
1.3%
1/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
4.1%
5/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
5.4%
7/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
1.2%
1/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Musculoskeletal and connective tissue disorders
Joint warmth
|
1.6%
2/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
3.8%
5/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
2.3%
3/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
2.3%
3/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
2.3%
3/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
3.3%
4/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
1.5%
2/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
1.2%
1/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
1.5%
2/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
2.4%
2/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Nervous system disorders
Cervical root pain
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Nervous system disorders
Dizziness
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Nervous system disorders
Headache
|
7.3%
9/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
11.5%
15/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
1.2%
1/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Nervous system disorders
Migraine
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Nervous system disorders
Nerve compression
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Nervous system disorders
Paraesthesia
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Nervous system disorders
Sciatica
|
1.6%
2/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Nervous system disorders
Syncope vasovagal
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Psychiatric disorders
Depression
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Psychiatric disorders
Panic attack
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Psychiatric disorders
Stress
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.81%
1/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.77%
1/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
|
Vascular disorders
Hypertension
|
1.6%
2/123 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/130 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/77 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
0.00%
0/83 • Initial treatment period: Day 1 to Week 26. Repeat treatment period: Week 26 to Week 30.
In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.
|
Additional Information
Genzyme Medical Information
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Phone: 800-745-4447
Results disclosure agreements
- Principal investigator is a sponsor employee In multi-site studies, principal investigator (PI) can publish after Genzyme publishes or 18 months after study completion. PI gives Genzyme a draft 60 days before publication. Genzyme can ask that confidential information be removed, and can defer publication another 60 days upon notifying PI that it will file a patent application on inventions contained in the draft.
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Restriction type: OTHER