Trial Outcomes & Findings for The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study (NCT NCT00105027)
NCT ID: NCT00105027
Last Updated: 2018-07-02
Results Overview
Visual acuity testing was done using electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity testing at 3 meters using the Electronic Visual Acuity Tester by a SCORE certified technician. A masked visual acuity examiner with no knowledge of treatment assignments performed visual acuity testing at the 4-month, 12-month, 24-month and 36-month visits. An E-ETDRS visual acuity score of 85 is approximately 20/20, and a score of 20 letters is approximately 20/400. A visual acuity letter score change of 15 is about three lines on a vision chart.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
682 participants
Primary outcome timeframe
Change from baseline to 12 months
Results posted on
2018-07-02
Participant Flow
Between November 8, 2004, and February 29, 2008, 271 patients with central retinal vein occlusion (CRVO) were enrolled from 66 clinical sites and 411 patients with branch retinal vein occlusion (BRVO) were enrolled from 75 clinical sites across the United States. Participant flow data are reported for the primary outcome measure (12 months).
Participant milestones
| Measure |
CRVO Observation
Standard care consists of observation of the macular edema.
|
CRVO 1 mg Dose Triamcinolone Acetonide
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
CRVO 4 mg Dose Triamcinolone Acetonide
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
BRVO Standard Care
Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
|
BRVO 1 mg Dose Triamcinolone Acetonide
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
BRVO 4 mg Dose Triamcinolone Acetonide
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
88
|
92
|
91
|
137
|
136
|
138
|
|
Overall Study
COMPLETED
|
73
|
83
|
82
|
121
|
121
|
125
|
|
Overall Study
NOT COMPLETED
|
15
|
9
|
9
|
16
|
15
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study
Baseline characteristics by cohort
| Measure |
CRVO Observation
n=88 Participants
Standard care consists of observation of the macular edema.
|
CRVO 1 mg Dose Triamcinolone Acetonide
n=92 Participants
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
CRVO 4 mg Dose Triamcinolone Acetonide
n=91 Participants
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
BRVO Standard Care
n=137 Participants
Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
|
BRVO 1 mg Dose Triamcinolone Acetonide
n=136 Participants
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
BRVO 4 mg Dose Triamcinolone Acetonide
n=138 Participants
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
Total
n=682 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
62 Participants
n=7 Participants
|
54 Participants
n=31 Participants
|
55 Participants
n=30 Participants
|
265 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
63 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
75 Participants
n=7 Participants
|
82 Participants
n=31 Participants
|
83 Participants
n=30 Participants
|
417 Participants
n=3 Participants
|
|
Age, Continuous
|
69.2 years
STANDARD_DEVIATION 12.8 • n=99 Participants
|
67.4 years
STANDARD_DEVIATION 12.4 • n=107 Participants
|
67.5 years
STANDARD_DEVIATION 12.0 • n=206 Participants
|
66.9 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
67.2 years
STANDARD_DEVIATION 11.5 • n=31 Participants
|
68.1 years
STANDARD_DEVIATION 10.6 • n=30 Participants
|
67.7 years
STANDARD_DEVIATION 11.2 • n=3 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
71 Participants
n=7 Participants
|
68 Participants
n=31 Participants
|
63 Participants
n=30 Participants
|
325 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
66 Participants
n=7 Participants
|
68 Participants
n=31 Participants
|
75 Participants
n=30 Participants
|
357 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
88 participants
n=99 Participants
|
92 participants
n=107 Participants
|
91 participants
n=206 Participants
|
137 participants
n=7 Participants
|
136 participants
n=31 Participants
|
138 participants
n=30 Participants
|
682 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 12 monthsVisual acuity testing was done using electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity testing at 3 meters using the Electronic Visual Acuity Tester by a SCORE certified technician. A masked visual acuity examiner with no knowledge of treatment assignments performed visual acuity testing at the 4-month, 12-month, 24-month and 36-month visits. An E-ETDRS visual acuity score of 85 is approximately 20/20, and a score of 20 letters is approximately 20/400. A visual acuity letter score change of 15 is about three lines on a vision chart.
Outcome measures
| Measure |
CRVO Observation
n=88 Participants
Standard care consists of observation of the macular edema.
|
CRVO 1 mg Dose Triamcinolone Acetonide
n=92 Participants
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
CRVO 4 mg Dose Triamcinolone Acetonide
n=91 Participants
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
BRVO Standard Care
n=137 Participants
Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
|
BRVO 1 mg Dose Triamcinolone Acetonide
n=136 Participants
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
BRVO 4 mg Dose Triamcinolone Acetonide
n=138 Participants
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
|---|---|---|---|---|---|---|
|
The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit
|
5 Participants
|
22 Participants
Interval -6.4 to 4.1
|
21 Participants
Interval -6.3 to 4.0
|
35 Participants
Interval 1.1 to 7.3
|
31 Participants
Interval 2.8 to 8.6
|
34 Participants
Interval 0.9 to 7.2
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants who attended month 12 visit
Outcome measures
| Measure |
CRVO Observation
n=73 Participants
Standard care consists of observation of the macular edema.
|
CRVO 1 mg Dose Triamcinolone Acetonide
n=83 Participants
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
CRVO 4 mg Dose Triamcinolone Acetonide
n=82 Participants
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
BRVO Standard Care
n=121 Participants
Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
|
BRVO 1 mg Dose Triamcinolone Acetonide
n=121 Participants
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
BRVO 4 mg Dose Triamcinolone Acetonide
n=125 Participants
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
|---|---|---|---|---|---|---|
|
Changes From Baseline in Best-corrected ETDRS Visual Acuity Score
|
-12.1 letters read
Interval -17.1 to -7.1
|
-1.2 letters read
Interval -6.4 to 4.1
|
-1.2 letters read
Interval -6.3 to 4.0
|
4.2 letters read
Interval 1.1 to 7.3
|
5.7 letters read
Interval 2.8 to 8.6
|
4.0 letters read
Interval 0.9 to 7.2
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants who attended month 12 visit
Outcome measures
| Measure |
CRVO Observation
n=68 Participants
Standard care consists of observation of the macular edema.
|
CRVO 1 mg Dose Triamcinolone Acetonide
n=72 Participants
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
CRVO 4 mg Dose Triamcinolone Acetonide
n=78 Participants
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
BRVO Standard Care
n=120 Participants
Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
|
BRVO 1 mg Dose Triamcinolone Acetonide
n=113 Participants
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
BRVO 4 mg Dose Triamcinolone Acetonide
n=112 Participants
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
|---|---|---|---|---|---|---|
|
Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography
|
-277 um
Interval -418.0 to -40.0
|
-196 um
Interval -390.0 to -62.0
|
-261 um
Interval -407.0 to -79.0
|
-224 um
Interval -411.0 to -67.0
|
-149 um
Interval -279.0 to -18.0
|
-170 um
Interval -304.0 to -63.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Participants experiencing an adverse event
Outcome measures
| Measure |
CRVO Observation
n=88 Participants
Standard care consists of observation of the macular edema.
|
CRVO 1 mg Dose Triamcinolone Acetonide
n=92 Participants
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
CRVO 4 mg Dose Triamcinolone Acetonide
n=91 Participants
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
BRVO Standard Care
n=137 Participants
Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
|
BRVO 1 mg Dose Triamcinolone Acetonide
n=136 Participants
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
BRVO 4 mg Dose Triamcinolone Acetonide
n=138 Participants
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
|---|---|---|---|---|---|---|
|
Adverse Ocular Outcomes
Initiation of IOP-lowering medications
|
7 events
|
18 events
|
32 events
|
3 events
|
11 events
|
57 events
|
|
Adverse Ocular Outcomes
IOP > 35 mm HG
|
1 events
|
5 events
|
8 events
|
1 events
|
2 events
|
14 events
|
|
Adverse Ocular Outcomes
IOP > 10 mm HG above baseline
|
2 events
|
15 events
|
24 events
|
1 events
|
12 events
|
50 events
|
|
Adverse Ocular Outcomes
Laser peripheral iridotomy
|
0 events
|
0 events
|
1 events
|
0 events
|
0 events
|
1 events
|
|
Adverse Ocular Outcomes
Trabeculectomy
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Adverse Ocular Outcomes
Tube shunt
|
0 events
|
2 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Adverse Ocular Outcomes
Cataract: lens opacity onset or progression
|
12 events
|
20 events
|
25 events
|
15 events
|
27 events
|
38 events
|
|
Adverse Ocular Outcomes
Cataract surgery
|
0 events
|
0 events
|
4 events
|
3 events
|
0 events
|
4 events
|
|
Adverse Ocular Outcomes
Infectious endophthalmitis
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
1 events
|
|
Adverse Ocular Outcomes
Noninfectious endophthalmitis
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Adverse Ocular Outcomes
Retinal detachment
|
0 events
|
0 events
|
0 events
|
1 events
|
1 events
|
0 events
|
|
Adverse Ocular Outcomes
Iris neovascularization
|
2 events
|
9 events
|
4 events
|
1 events
|
1 events
|
2 events
|
|
Adverse Ocular Outcomes
Retinal neovascularization
|
4 events
|
2 events
|
2 events
|
5 events
|
1 events
|
3 events
|
|
Adverse Ocular Outcomes
Vitreous hemorrhage
|
4 events
|
4 events
|
0 events
|
2 events
|
1 events
|
3 events
|
|
Adverse Ocular Outcomes
YAG capsulotomy
|
1 events
|
0 events
|
0 events
|
1 events
|
0 events
|
1 events
|
|
Adverse Ocular Outcomes
Sector or panretinal photocagulation
|
5 events
|
9 events
|
3 events
|
5 events
|
1 events
|
4 events
|
|
Adverse Ocular Outcomes
Pars plana vitrectomy
|
1 events
|
2 events
|
0 events
|
1 events
|
0 events
|
1 events
|
Adverse Events
CRVO Observation
Serious events: 32 serious events
Other events: 76 other events
Deaths: 0 deaths
CRVO 1 mg Dose Triamcinolone Acetonide
Serious events: 37 serious events
Other events: 87 other events
Deaths: 1 deaths
CRVO 4 mg Dose Triamcinolone Acetonide
Serious events: 53 serious events
Other events: 89 other events
Deaths: 2 deaths
BRVO Standard Care
Serious events: 47 serious events
Other events: 118 other events
Deaths: 3 deaths
BRVO 1 mg Dose Triamcinolone Acetonide
Serious events: 49 serious events
Other events: 132 other events
Deaths: 2 deaths
BRVO 4 mg Dose Triamcinolone Acetonide
Serious events: 79 serious events
Other events: 133 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
CRVO Observation
n=88 participants at risk
Standard care consists of observation of the macular edema.
|
CRVO 1 mg Dose Triamcinolone Acetonide
n=92 participants at risk
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
CRVO 4 mg Dose Triamcinolone Acetonide
n=91 participants at risk
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
BRVO Standard Care
n=137 participants at risk
Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
|
BRVO 1 mg Dose Triamcinolone Acetonide
n=136 participants at risk
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
BRVO 4 mg Dose Triamcinolone Acetonide
n=138 participants at risk
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
General disorders
Pyrexia
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Gastrointestinal disorders
Abdominal hernia
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Infections and infestations
Abdominal wall abscess
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Cardiac disorders
Angina unstable
|
3.4%
3/88 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Anisometropia
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Anterior chamber disorder
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.5%
2/136 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
2/91 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
General disorders
Asthenia
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
2/92 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Renal and urinary disorders
Automatic bladder
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign colonic neoplasm
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.5%
2/136 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
3/137 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Renal and urinary disorders
Bladder disorder
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Investigations
Blood glucose increased
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Investigations
Blood pressure increased
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer metastatic
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
2/92 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
2/91 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.4%
2/138 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Cardiac disorders
Cardiovascular disorder
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Nervous system disorders
Carotid artery disease
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Cataract
|
5.7%
5/88 • Number of events 5 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
9.8%
9/92 • Number of events 10 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
30.8%
28/91 • Number of events 30 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
8.8%
12/137 • Number of events 16 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
11.8%
16/136 • Number of events 18 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
29.0%
40/138 • Number of events 46 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Cataract cortical
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.4%
2/138 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Cataract subcapsular
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
8.7%
12/138 • Number of events 12 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Infections and infestations
Cellulitis
|
2.3%
2/88 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.5%
2/136 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Nervous system disorders
Central nervous system lesion
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.3%
2/88 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
4.4%
4/91 • Number of events 5 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
3/137 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
3/138 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
General disorders
Chest discomfort
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
General disorders
Chest pain
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
3/137 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.4%
2/138 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.4%
2/138 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Choroidal neovascularisation
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Injury, poisoning and procedural complications
Conjunctival filtering bleb leak
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Cardiac disorders
Coronary artery disease
|
2.3%
2/88 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.4%
2/138 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Infections and infestations
Cystitis
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Reproductive system and breast disorders
Cystocele
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
General disorders
Death
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.4%
2/138 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Gastrointestinal disorders
Diverticular hernia
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
2/92 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
2/91 • Number of events 4 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.5%
2/137 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.4%
2/138 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Endophthalmitis
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Eye pain
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Surgical and medical procedures
Finger amputation
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Hepatobiliary disorders
Gallbladder pain
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Gastrointestinal disorders
Gastritis
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Infections and infestations
Gastroenteritis
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Injury, poisoning and procedural complications
Gastroenteritis radiation
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
2/91 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Gastrointestinal disorders
Gastrointestinal oedema
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Glaucoma
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
5.4%
5/92 • Number of events 5 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
3.3%
3/91 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.4%
2/138 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Gastrointestinal disorders
Haematochezia
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Investigations
Heart rate decreased
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Investigations
Heart rate increased
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Investigations
Heart rate irregular
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.1%
1/88 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Vascular disorders
Hypotension
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Infections and infestations
Infection
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Investigations
Intraocular pressure increased
|
3.4%
3/88 • Number of events 4 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
2/92 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
3.3%
3/91 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.9%
4/138 • Number of events 4 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Iris neovascularisation
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
2/92 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Nervous system disorders
Lumbar radiculopathy
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Infections and infestations
Lung infection
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
3.3%
3/91 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Macular hole
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Maculopathy
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
2/91 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.5%
2/136 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.4%
2/138 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Surgical and medical procedures
Nephrectomy
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Optic nerve cupping
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.5%
2/137 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Cardiac disorders
Palpitations
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Vascular disorders
Peripheral vascular disorder
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Infections and infestations
Pneumonia
|
2.3%
2/88 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
2/92 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.9%
4/136 • Number of events 4 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.4%
2/138 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
General disorders
Polyp
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.5%
2/137 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.5%
2/136 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Reproductive system and breast disorders
Prostatic mass
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Renal and urinary disorders
Renal impairment
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
2/92 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.5%
2/136 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Retinal neovascularisation
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Retinal tear
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Retinopathy proliferative
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Infections and infestations
Sepsis
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal cord neoplasm
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Nervous system disorders
Syncope
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
3.3%
3/91 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat cancer
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Nervous system disorders
Transient ischaemic attack
|
2.3%
2/88 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.5%
2/137 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.5%
2/137 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Uveitis
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Surgical and medical procedures
Vascular graft
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Vitreous haemorrhage
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/91 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Vitreous prolapse
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/92 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/138 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
Other adverse events
| Measure |
CRVO Observation
n=88 participants at risk
Standard care consists of observation of the macular edema.
|
CRVO 1 mg Dose Triamcinolone Acetonide
n=92 participants at risk
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
CRVO 4 mg Dose Triamcinolone Acetonide
n=91 participants at risk
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
BRVO Standard Care
n=137 participants at risk
Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
|
BRVO 1 mg Dose Triamcinolone Acetonide
n=136 participants at risk
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
BRVO 4 mg Dose Triamcinolone Acetonide
n=138 participants at risk
Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
|
|---|---|---|---|---|---|---|
|
Eye disorders
Blepharitis
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
3.3%
3/92 • Number of events 5 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
8.8%
8/91 • Number of events 19 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.9%
4/137 • Number of events 8 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
6.6%
9/136 • Number of events 16 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
4.3%
6/138 • Number of events 11 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Infections and infestations
Bronchitis
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
3.3%
3/92 • Number of events 4 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
5.5%
5/91 • Number of events 6 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
3.6%
5/137 • Number of events 6 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
3/136 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.9%
4/138 • Number of events 4 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Cataract
|
11.4%
10/88 • Number of events 14 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
9.8%
9/92 • Number of events 12 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
15.4%
14/91 • Number of events 16 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
10.9%
15/137 • Number of events 27 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
14.0%
19/136 • Number of events 28 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
15.2%
21/138 • Number of events 25 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Cataract subcapsular
|
3.4%
3/88 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
8.7%
8/92 • Number of events 8 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
13.2%
12/91 • Number of events 12 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.5%
2/137 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
9.6%
13/136 • Number of events 14 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
11.6%
16/138 • Number of events 18 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Conjunctival haemorrhage
|
3.4%
3/88 • Number of events 7 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
37.0%
34/92 • Number of events 54 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
33.0%
30/91 • Number of events 57 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
6.6%
9/137 • Number of events 9 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
39.7%
54/136 • Number of events 88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
39.1%
54/138 • Number of events 82 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
5.4%
5/92 • Number of events 5 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
4.4%
6/136 • Number of events 6 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.9%
4/138 • Number of events 4 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Dry eye
|
3.4%
3/88 • Number of events 6 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
3.3%
3/92 • Number of events 5 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
2/91 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
3.6%
5/137 • Number of events 12 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
5.1%
7/136 • Number of events 13 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
4.3%
6/138 • Number of events 10 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Eye irritation
|
2.3%
2/88 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
12.0%
11/92 • Number of events 12 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
9.9%
9/91 • Number of events 14 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
4.4%
6/137 • Number of events 8 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
12.5%
17/136 • Number of events 28 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
5.8%
8/138 • Number of events 9 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Eye pain
|
6.8%
6/88 • Number of events 6 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
16.3%
15/92 • Number of events 25 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
19.8%
18/91 • Number of events 36 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
6.6%
9/137 • Number of events 13 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
16.9%
23/136 • Number of events 34 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
13.0%
18/138 • Number of events 26 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
6.6%
6/91 • Number of events 8 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
3.6%
5/137 • Number of events 7 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/136 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
7.2%
10/138 • Number of events 11 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
5.7%
5/88 • Number of events 5 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
33.7%
31/92 • Number of events 31 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
24.2%
22/91 • Number of events 22 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.9%
4/137 • Number of events 4 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
49.3%
67/136 • Number of events 67 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
22.5%
31/138 • Number of events 31 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Foreign body sensation in eyes
|
4.5%
4/88 • Number of events 5 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
8.7%
8/92 • Number of events 8 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
3.3%
3/91 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.73%
1/137 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
9.6%
13/136 • Number of events 13 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
8.7%
12/138 • Number of events 14 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Glaucoma
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
5.5%
5/91 • Number of events 5 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.5%
2/137 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
4.3%
6/138 • Number of events 7 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Nervous system disorders
Headache
|
6.8%
6/88 • Number of events 6 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
5.4%
5/92 • Number of events 5 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
7.7%
7/91 • Number of events 8 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.9%
4/137 • Number of events 4 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.9%
4/136 • Number of events 6 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
3.6%
5/138 • Number of events 9 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
4.5%
4/88 • Number of events 4 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/92 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
5.5%
5/91 • Number of events 5 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.9%
4/137 • Number of events 4 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
4.4%
6/136 • Number of events 6 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
4.3%
6/138 • Number of events 7 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Vascular disorders
Hypertension
|
2.3%
2/88 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
2/92 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
4.4%
4/91 • Number of events 4 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
4.4%
6/137 • Number of events 6 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
8.8%
12/136 • Number of events 12 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
8.7%
12/138 • Number of events 12 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Investigations
Intraocular pressure increased
|
9.1%
8/88 • Number of events 10 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
21.7%
20/92 • Number of events 24 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
46.2%
42/91 • Number of events 55 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
5.1%
7/137 • Number of events 9 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
14.0%
19/136 • Number of events 24 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
46.4%
64/138 • Number of events 88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Iris neovascularisation
|
2.3%
2/88 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
6.5%
6/92 • Number of events 7 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
3.3%
3/91 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.00%
0/137 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.5%
2/136 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Lacrimation increased
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
5.4%
5/92 • Number of events 6 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
4.4%
4/91 • Number of events 7 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
3.6%
5/137 • Number of events 8 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
3.7%
5/136 • Number of events 7 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
4.3%
6/138 • Number of events 7 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Macular oedema
|
2.3%
2/88 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
6.5%
6/92 • Number of events 6 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
2/91 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
3/137 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
3/136 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.72%
1/138 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Maculopathy
|
5.7%
5/88 • Number of events 5 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
9.8%
9/92 • Number of events 10 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
11.0%
10/91 • Number of events 10 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
6.6%
9/137 • Number of events 10 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
8.8%
12/136 • Number of events 14 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
6.5%
9/138 • Number of events 10 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Myodesopsia
|
9.1%
8/88 • Number of events 9 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
34.8%
32/92 • Number of events 44 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
37.4%
34/91 • Number of events 52 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
12.4%
17/137 • Number of events 23 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
43.4%
59/136 • Number of events 81 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
32.6%
45/138 • Number of events 64 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
2/92 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
6.6%
6/91 • Number of events 7 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
5.8%
8/137 • Number of events 8 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
3.7%
5/136 • Number of events 6 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
6.5%
9/138 • Number of events 10 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Photopsia
|
3.4%
3/88 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
7.6%
7/92 • Number of events 8 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
4.4%
4/91 • Number of events 4 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
3.6%
5/137 • Number of events 6 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
7.4%
10/136 • Number of events 11 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
3.6%
5/138 • Number of events 6 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Retinal haemorrhage
|
1.1%
1/88 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
6.5%
6/92 • Number of events 6 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.9%
4/137 • Number of events 5 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.4%
2/138 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Retinal neovascularisation
|
6.8%
6/88 • Number of events 6 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
4.3%
4/92 • Number of events 4 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
6.6%
6/91 • Number of events 6 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
4.4%
6/137 • Number of events 8 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
0.74%
1/136 • Number of events 1 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
3.6%
5/138 • Number of events 5 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Retinal vascular disorder
|
0.00%
0/88 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
6.5%
6/92 • Number of events 6 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.1%
1/91 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.5%
2/137 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.9%
4/136 • Number of events 4 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
3/138 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Retinal vein occlusion
|
4.5%
4/88 • Number of events 4 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
4.3%
4/92 • Number of events 4 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
3.3%
3/91 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
4.4%
6/137 • Number of events 6 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
3/136 • Number of events 3 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
5.8%
8/138 • Number of events 10 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Vision blurred
|
5.7%
5/88 • Number of events 6 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
6.5%
6/92 • Number of events 11 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
9.9%
9/91 • Number of events 13 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
10.2%
14/137 • Number of events 19 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
11.0%
15/136 • Number of events 19 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
12.3%
17/138 • Number of events 22 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Visual acuity reduced
|
11.4%
10/88 • Number of events 10 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
13.0%
12/92 • Number of events 14 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
11.0%
10/91 • Number of events 15 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
4.4%
6/137 • Number of events 11 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
8.1%
11/136 • Number of events 12 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
9.4%
13/138 • Number of events 15 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Visual impairment
|
5.7%
5/88 • Number of events 5 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
5.4%
5/92 • Number of events 5 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
3.3%
3/91 • Number of events 4 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
8.0%
11/137 • Number of events 14 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
6.6%
9/136 • Number of events 10 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
5.1%
7/138 • Number of events 10 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Vitreous detachment
|
9.1%
8/88 • Number of events 9 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
17.4%
16/92 • Number of events 19 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
11.0%
10/91 • Number of events 12 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
10.9%
15/137 • Number of events 20 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
15.4%
21/136 • Number of events 25 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
8.7%
12/138 • Number of events 14 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
|
Eye disorders
Vitreous haemorrhage
|
8.0%
7/88 • Number of events 7 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
8.7%
8/92 • Number of events 8 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
2.2%
2/91 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
1.5%
2/137 • Number of events 2 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
3.7%
5/136 • Number of events 5 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
3.6%
5/138 • Number of events 5 • Three years
Clinical sites were required to report all adverse events via an electronic data capture system. Electronic forms designed to collect adverse event data were available for input at any time, including between scheduled visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place