Trial Outcomes & Findings for Cardiovascular Inflammation Reduction Trial (NCT NCT01594333)
NCT ID: NCT01594333
Last Updated: 2020-07-24
Results Overview
The first occurrence of Major Adverse Cardiovascular Event which is defined as the occurrence of one or more of the following: Cardiovascular Death, Non-Fatal Myocardial Infarction or Non-Fatal Stroke.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4786 participants
Primary outcome timeframe
From randomization to trial end (April 2, 2018) up to a maximum of 5 years
Results posted on
2020-07-24
Participant Flow
9321 subjects were screened and 4786 subjects were randomized starting from April, 2013 through March 2018 in 417 clinical sites in Canada and the United States
9321 subjects were screened, 2987 were found to be ineligible and 176 were discontinued due to premature trial closure prior to entering the open label run-in. 6158 started the run-in. Of those, 1171 were ineligible, 201 were discontinued due to premature trial closure and 4786 subjects were randomly assigned to either Methotrexate or Placebo
Participant milestones
| Measure |
Methotrexate
Methotrexate: Tablet, Oral, Target dose 15-20 mg weekly plus 1.0 mg folic acid 6 days/week
|
Placebo
Placebo: Tablet, Oral, weekly plus 1.0 mg folic acid 6 days/week
|
|---|---|---|
|
Overall Study
STARTED
|
2391
|
2395
|
|
Overall Study
COMPLETED
|
2230
|
2244
|
|
Overall Study
NOT COMPLETED
|
161
|
151
|
Reasons for withdrawal
| Measure |
Methotrexate
Methotrexate: Tablet, Oral, Target dose 15-20 mg weekly plus 1.0 mg folic acid 6 days/week
|
Placebo
Placebo: Tablet, Oral, weekly plus 1.0 mg folic acid 6 days/week
|
|---|---|---|
|
Overall Study
Death
|
96
|
83
|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
|
Overall Study
Withdrawal by Subject
|
60
|
63
|
Baseline Characteristics
One subject is missing this information
Baseline characteristics by cohort
| Measure |
Methotrexate
n=2391 Participants
Methotrexate: Tablet, Oral, Target dose 15-20 mg weekly plus 1.0 mg folic acid 6 days/week
|
Placebo
n=2395 Participants
Placebo: Tablet, Oral, weekly plus 1.0 mg folic acid 6 days/week
|
Total
n=4786 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.6 years
n=2391 Participants
|
66.0 years
n=2395 Participants
|
65.8 years
n=4786 Participants
|
|
Sex: Female, Male
Female
|
461 Participants
n=2391 Participants
|
437 Participants
n=2395 Participants
|
898 Participants
n=4786 Participants
|
|
Sex: Female, Male
Male
|
1930 Participants
n=2391 Participants
|
1958 Participants
n=2395 Participants
|
3888 Participants
n=4786 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
206 Participants
n=2391 Participants
|
177 Participants
n=2395 Participants
|
383 Participants
n=4786 Participants
|
|
Race/Ethnicity, Customized
White/Non-hispanic or Latino
|
1801 Participants
n=2391 Participants
|
1837 Participants
n=2395 Participants
|
3638 Participants
n=4786 Participants
|
|
Race/Ethnicity, Customized
Asian
|
89 Participants
n=2391 Participants
|
92 Participants
n=2395 Participants
|
181 Participants
n=4786 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
186 Participants
n=2391 Participants
|
152 Participants
n=2395 Participants
|
338 Participants
n=4786 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
6 Participants
n=2391 Participants
|
6 Participants
n=2395 Participants
|
12 Participants
n=4786 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
3 Participants
n=2391 Participants
|
6 Participants
n=2395 Participants
|
9 Participants
n=4786 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
13 Participants
n=2391 Participants
|
7 Participants
n=2395 Participants
|
20 Participants
n=4786 Participants
|
|
Race/Ethnicity, Customized
Other
|
42 Participants
n=2391 Participants
|
45 Participants
n=2395 Participants
|
87 Participants
n=4786 Participants
|
|
Race/Ethnicity, Customized
White, Unknown Ethnicity
|
45 Participants
n=2391 Participants
|
73 Participants
n=2395 Participants
|
118 Participants
n=4786 Participants
|
|
Region of Enrollment
Canada
|
407 participants
n=2391 Participants
|
404 participants
n=2395 Participants
|
811 participants
n=4786 Participants
|
|
Region of Enrollment
Puerto Rico
|
19 participants
n=2391 Participants
|
17 participants
n=2395 Participants
|
36 participants
n=4786 Participants
|
|
Region of Enrollment
United States
|
1965 participants
n=2391 Participants
|
1974 participants
n=2395 Participants
|
3939 participants
n=4786 Participants
|
|
Smoking status
Current smoker
|
267 Participants
n=2391 Participants
|
270 Participants
n=2395 Participants
|
537 Participants
n=4786 Participants
|
|
Smoking status
Past smoker
|
1173 Participants
n=2391 Participants
|
1215 Participants
n=2395 Participants
|
2388 Participants
n=4786 Participants
|
|
Smoking status
Never smoked cigarettes
|
951 Participants
n=2391 Participants
|
910 Participants
n=2395 Participants
|
1861 Participants
n=4786 Participants
|
|
Alcohol use
Rarely/Never
|
1487 Participants
n=2391 Participants
|
1473 Participants
n=2395 Participants
|
2960 Participants
n=4786 Participants
|
|
Alcohol use
<=1 drink/week
|
514 Participants
n=2391 Participants
|
520 Participants
n=2395 Participants
|
1034 Participants
n=4786 Participants
|
|
Alcohol use
>1 drink/week
|
390 Participants
n=2391 Participants
|
402 Participants
n=2395 Participants
|
792 Participants
n=4786 Participants
|
|
Body Mass Index
|
31.6 kilograms per meter squared
n=2391 Participants
|
31.3 kilograms per meter squared
n=2395 Participants
|
31.5 kilograms per meter squared
n=4786 Participants
|
|
History of diagnosed hypertension
Yes
|
2153 Participants
n=2391 Participants • One subject is missing this information
|
2169 Participants
n=2394 Participants • One subject is missing this information
|
4322 Participants
n=4785 Participants • One subject is missing this information
|
|
History of diagnosed hypertension
No
|
238 Participants
n=2391 Participants • One subject is missing this information
|
225 Participants
n=2394 Participants • One subject is missing this information
|
463 Participants
n=4785 Participants • One subject is missing this information
|
|
Qualifying event
Myocardial infarction
|
1451 Participants
n=2391 Participants
|
1458 Participants
n=2395 Participants
|
2909 Participants
n=4786 Participants
|
|
Qualifying event
Multivessel coronary disease
|
940 Participants
n=2391 Participants
|
937 Participants
n=2395 Participants
|
1877 Participants
n=4786 Participants
|
|
Qualifying coexisting condition
Diabetes only
|
788 Participants
n=2391 Participants
|
823 Participants
n=2395 Participants
|
1611 Participants
n=4786 Participants
|
|
Qualifying coexisting condition
Metabolic syndrome only
|
771 Participants
n=2391 Participants
|
780 Participants
n=2395 Participants
|
1551 Participants
n=4786 Participants
|
|
Qualifying coexisting condition
Diabests and metabolic syndrome
|
832 Participants
n=2391 Participants
|
792 Participants
n=2395 Participants
|
1624 Participants
n=4786 Participants
|
|
History of congestive heart failure
Yes
|
288 Participants
n=2391 Participants • One subject is missing this information
|
332 Participants
n=2394 Participants • One subject is missing this information
|
620 Participants
n=4785 Participants • One subject is missing this information
|
|
History of congestive heart failure
No
|
2103 Participants
n=2391 Participants • One subject is missing this information
|
2062 Participants
n=2394 Participants • One subject is missing this information
|
4165 Participants
n=4785 Participants • One subject is missing this information
|
|
History of percutaneous coronary intervention
Yes
|
1396 Participants
n=2391 Participants • One subject is missing this information
|
1420 Participants
n=2394 Participants • One subject is missing this information
|
2816 Participants
n=4785 Participants • One subject is missing this information
|
|
History of percutaneous coronary intervention
No
|
995 Participants
n=2391 Participants • One subject is missing this information
|
974 Participants
n=2394 Participants • One subject is missing this information
|
1969 Participants
n=4785 Participants • One subject is missing this information
|
|
History of coronary-artery bypass grafting
Yes
|
1010 Participants
n=2391 Participants • One subject is missing this information
|
1032 Participants
n=2394 Participants • One subject is missing this information
|
2042 Participants
n=4785 Participants • One subject is missing this information
|
|
History of coronary-artery bypass grafting
No
|
1381 Participants
n=2391 Participants • One subject is missing this information
|
1362 Participants
n=2394 Participants • One subject is missing this information
|
2743 Participants
n=4785 Participants • One subject is missing this information
|
|
Family history of premature myocardial infarction
Yes
|
550 Participants
n=2118 Participants • 552 subjects are missing this information
|
536 Participants
n=2116 Participants • 552 subjects are missing this information
|
1086 Participants
n=4234 Participants • 552 subjects are missing this information
|
|
Family history of premature myocardial infarction
No
|
1568 Participants
n=2118 Participants • 552 subjects are missing this information
|
1580 Participants
n=2116 Participants • 552 subjects are missing this information
|
3148 Participants
n=4234 Participants • 552 subjects are missing this information
|
|
Family history of premature stroke
Yes
|
142 Participants
n=2144 Participants • 482 subjects are missing this information
|
136 Participants
n=2160 Participants • 482 subjects are missing this information
|
278 Participants
n=4304 Participants • 482 subjects are missing this information
|
|
Family history of premature stroke
No
|
2002 Participants
n=2144 Participants • 482 subjects are missing this information
|
2024 Participants
n=2160 Participants • 482 subjects are missing this information
|
4026 Participants
n=4304 Participants • 482 subjects are missing this information
|
|
Use of ACE inhibitor or ARB
Yes
|
1736 Participants
n=2391 Participants
|
1724 Participants
n=2395 Participants
|
3460 Participants
n=4786 Participants
|
|
Use of ACE inhibitor or ARB
No
|
655 Participants
n=2391 Participants
|
671 Participants
n=2395 Participants
|
1326 Participants
n=4786 Participants
|
|
Use of a statin
Yes
|
2058 Participants
n=2391 Participants
|
2052 Participants
n=2395 Participants
|
4110 Participants
n=4786 Participants
|
|
Use of a statin
No
|
333 Participants
n=2391 Participants
|
343 Participants
n=2395 Participants
|
676 Participants
n=4786 Participants
|
|
Use of a beta-blocker
Yes
|
1870 Participants
n=2391 Participants
|
1905 Participants
n=2395 Participants
|
3775 Participants
n=4786 Participants
|
|
Use of a beta-blocker
No
|
521 Participants
n=2391 Participants
|
490 Participants
n=2395 Participants
|
1011 Participants
n=4786 Participants
|
|
Use of antiplatelet or antithrombotic agent
Yes
|
2082 Participants
n=2391 Participants
|
2054 Participants
n=2395 Participants
|
4136 Participants
n=4786 Participants
|
|
Use of antiplatelet or antithrombotic agent
No
|
309 Participants
n=2391 Participants
|
341 Participants
n=2395 Participants
|
650 Participants
n=4786 Participants
|
|
Total cholesterol
|
141.0 mg/dL
n=2369 Participants • 45 subjects are missing this information
|
140.9 mg/dL
n=2372 Participants • 45 subjects are missing this information
|
141.0 mg/dL
n=4741 Participants • 45 subjects are missing this information
|
|
Low density lipoprotein cholesterol
|
68.0 mg/dL
n=2288 Participants • 192 subjects are missing this information
|
68.0 mg/dL
n=2306 Participants • 192 subjects are missing this information
|
68.0 mg/dL
n=4594 Participants • 192 subjects are missing this information
|
|
High density lipoprotein cholesterol
|
41.0 mg/dL
n=2369 Participants • 45 subjects are missing this information
|
41.0 mg/dL
n=2372 Participants • 45 subjects are missing this information
|
41.0 mg/dL
n=4741 Participants • 45 subjects are missing this information
|
|
Triglycerides
|
135.4 mg/dL
n=2369 Participants • 45 subjects are missing this information
|
136.0 mg/dL
n=2372 Participants • 45 subjects are missing this information
|
135.4 mg/dL
n=4741 Participants • 45 subjects are missing this information
|
|
High-sensitivity C-reactive protein level
|
1.53 mg/liter
n=2343 Participants • 95 subjects are missing this information
|
1.50 mg/liter
n=2348 Participants • 95 subjects are missing this information
|
1.51 mg/liter
n=4691 Participants • 95 subjects are missing this information
|
|
Glycated hemoglobin level
|
6.6 %
n=2372 Participants • 36 subjects are missing this information
|
6.5 %
n=2378 Participants • 36 subjects are missing this information
|
6.5 %
n=4750 Participants • 36 subjects are missing this information
|
PRIMARY outcome
Timeframe: From randomization to trial end (April 2, 2018) up to a maximum of 5 yearsPopulation: All randomized subjects
The first occurrence of Major Adverse Cardiovascular Event which is defined as the occurrence of one or more of the following: Cardiovascular Death, Non-Fatal Myocardial Infarction or Non-Fatal Stroke.
Outcome measures
| Measure |
Methotrexate
n=2391 Participants
Methotrexate: Tablet, Oral, Target dose 15-20 mg weekly plus 1.0 mg folic acid 6 days/week
|
Placebo
n=2395 Participants
Placebo: Tablet, Oral, weekly plus 1.0 mg folic acid 6 days/week
|
|---|---|---|
|
Number of Subjects With Major Adverse Cardiovascular Events
|
170 participants
|
167 participants
|
PRIMARY outcome
Timeframe: From randomization to trial end (April 2, 2018) - up to a maximum of 5 yearsPopulation: All randomized participants
The first occurrence of Major Adverse Cardiovascular Event or Hospitalization for Unstable Angina that led to Urgent Coronary Revascularization.
Outcome measures
| Measure |
Methotrexate
n=2391 Participants
Methotrexate: Tablet, Oral, Target dose 15-20 mg weekly plus 1.0 mg folic acid 6 days/week
|
Placebo
n=2395 Participants
Placebo: Tablet, Oral, weekly plus 1.0 mg folic acid 6 days/week
|
|---|---|---|
|
Number of Subjects With Major Adverse Cardiovascular Event or Hospitalization for Unstable Angina That Led to Urgent Coronary Revascularization
|
201 participants
|
207 participants
|
SECONDARY outcome
Timeframe: From randomization to the trial end (April 2, 2018) up to a maximum of 5 yearsPopulation: All Randomized Participants
Subjects who died from any cause.
Outcome measures
| Measure |
Methotrexate
n=2391 Participants
Methotrexate: Tablet, Oral, Target dose 15-20 mg weekly plus 1.0 mg folic acid 6 days/week
|
Placebo
n=2395 Participants
Placebo: Tablet, Oral, weekly plus 1.0 mg folic acid 6 days/week
|
|---|---|---|
|
Number of Subjects With All-cause Mortality
|
96 participants
|
83 participants
|
SECONDARY outcome
Timeframe: From randomization to the trial end (April 2, 2018) - up to a maximum of 5 yearsPopulation: All randomized participants
The first occurrence of Major Adverse Cardiovascular Event or Any Coronary Revascularization.
Outcome measures
| Measure |
Methotrexate
n=2391 Participants
Methotrexate: Tablet, Oral, Target dose 15-20 mg weekly plus 1.0 mg folic acid 6 days/week
|
Placebo
n=2395 Participants
Placebo: Tablet, Oral, weekly plus 1.0 mg folic acid 6 days/week
|
|---|---|---|
|
Number of Subjects With Major Adverse Cardiovascular Event or Any Coronary Revascularization
|
278 participants
|
288 participants
|
SECONDARY outcome
Timeframe: From randomization to trial end (April 2, 2018) up to a maximum of 5 yearsPopulation: All randomized participants
The first occurrence of Hospitalization for Congestive Heart Failure
Outcome measures
| Measure |
Methotrexate
n=2391 Participants
Methotrexate: Tablet, Oral, Target dose 15-20 mg weekly plus 1.0 mg folic acid 6 days/week
|
Placebo
n=2395 Participants
Placebo: Tablet, Oral, weekly plus 1.0 mg folic acid 6 days/week
|
|---|---|---|
|
Number of Subjects With Hospitalization for Congestive Heart Failure
|
48 participants
|
53 participants
|
SECONDARY outcome
Timeframe: From randomization to trial end (April 2, 2018) up to a maximum of 5 yearsPopulation: All randomized participants
The first occurrence of Major Adverse Cardiovascular Event, Coronary Revascularization, Hospitalization for Congestive Heart Failure or All Cause Mortality.
Outcome measures
| Measure |
Methotrexate
n=2391 Participants
Methotrexate: Tablet, Oral, Target dose 15-20 mg weekly plus 1.0 mg folic acid 6 days/week
|
Placebo
n=2395 Participants
Placebo: Tablet, Oral, weekly plus 1.0 mg folic acid 6 days/week
|
|---|---|---|
|
Number of Subjects With Major Adverse Cardiovascular Event, Coronary Revascularization, Hospitalization for Congestive Heart Failure or All Cause Mortality
|
344 participants
|
345 participants
|
SECONDARY outcome
Timeframe: From randomization to the trial end (April 2, 2018) - up to 5 yearsPopulation: Randomized participants without pre-randomization diabetes
New onset type 2 diabetes among those without diabetes at baseline. Baseline diabetes is defined as any of the following prior to randomization: clinician report of diabetes, use of antidiabetic medication, hbA1c \>=6.5 or fasting plasma glucose \>=126.
Outcome measures
| Measure |
Methotrexate
n=605 Participants
Methotrexate: Tablet, Oral, Target dose 15-20 mg weekly plus 1.0 mg folic acid 6 days/week
|
Placebo
n=620 Participants
Placebo: Tablet, Oral, weekly plus 1.0 mg folic acid 6 days/week
|
|---|---|---|
|
Number of Subjects With New Onset Type 2 Diabetes
|
4 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to the trial end (April 2, 2018) up to 5 yearsPopulation: All randomized participants
The first occurrence of hospitalization for unstable angina that led to unplanned coronary revascularization
Outcome measures
| Measure |
Methotrexate
n=2391 Participants
Methotrexate: Tablet, Oral, Target dose 15-20 mg weekly plus 1.0 mg folic acid 6 days/week
|
Placebo
n=2395 Participants
Placebo: Tablet, Oral, weekly plus 1.0 mg folic acid 6 days/week
|
|---|---|---|
|
Number of Subjects With Hospitalization for Unstable Angina That Led to Unplanned Coronary Revascularization
|
41 participants
|
50 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to trial end (April 2, 2018) up to 5 yearsPopulation: All randomized participants
The first occurrence of coronary revascularization
Outcome measures
| Measure |
Methotrexate
n=2391 Participants
Methotrexate: Tablet, Oral, Target dose 15-20 mg weekly plus 1.0 mg folic acid 6 days/week
|
Placebo
n=2395 Participants
Placebo: Tablet, Oral, weekly plus 1.0 mg folic acid 6 days/week
|
|---|---|---|
|
Number of Subjects With Coronary Revascularization
|
190 participants
|
205 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to the trial end (April 2, 2018) - up to 5 yearsThe first occurrence of new or worsening of peripheral artery disease
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to the trial end (April 2, 2018) - up to 5 yearsPopulation: The trial was ended prematurely. There were not sufficient outcome measures for analysis
The first occurrence of symptomatic deep vein thrombosis or pulmonary embolism
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to the trial end (April 2, 2018) - up to 5 yearsPopulation: The trial ended prematurely. There were not sufficient outcome measures for analysis.
The first occurrence of clinically significant aortic stenosis
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From randomization to the trial end (April 2, 2018) - up to 5 yearsThe first occurrence of new or worsening of atrial fibrillation
Outcome measures
Outcome data not reported
Adverse Events
Methotrexate
Serious events: 569 serious events
Other events: 1488 other events
Deaths: 96 deaths
Placebo
Serious events: 549 serious events
Other events: 1399 other events
Deaths: 83 deaths
Serious adverse events
| Measure |
Methotrexate
n=2391 participants at risk
Methotrexate: Tablet, Oral, Target dose 15-20 mg weekly plus 1.0 mg folic acid 6 days/week
|
Placebo
n=2395 participants at risk
Placebo: Tablet, Oral, weekly plus 1.0 mg folic acid 6 days/week
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Vascular disorders
Temporal arteritis
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.21%
5/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.17%
4/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.13%
3/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Renal and urinary disorders
Bladder mass
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Pneumonia
|
1.2%
29/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
1.2%
28/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Cellulitis
|
0.79%
19/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.63%
15/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Urinary tract infection
|
0.50%
12/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.38%
9/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Sepsis
|
0.50%
12/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.29%
7/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Infection
|
0.25%
6/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.29%
7/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Diverticulitis
|
0.17%
4/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.33%
8/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Bronchitis
|
0.29%
7/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Osteomyelitis
|
0.33%
8/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Gastroenteritis
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.17%
4/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Influenza
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.17%
4/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Localised infection
|
0.17%
4/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Pyelonephritis
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Septic shock
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Bacteraemia
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Gastroenteritis viral
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Urosepsis
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Abdominal wall abscess
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Abscess limb
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Bacterial disease carrier
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Bronchitis viral
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Groin abscess
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Sinusitis
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Skin infection
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Staphylococcal infection
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Abscess
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Anal abscess
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Atypical pneumonia
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Bacterial sepsis
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Cholecystitis infective
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Device related infection
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Enterobacter infection
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Epididymitis
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Escherichia infection
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Gangrene
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Gastroenteritis shigella
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Genital herpes
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Lyme disease
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Perineal abscess
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Pharyngitis
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Pneumonia bacterial
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Viral infection
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Infections and infestations
Wound infection
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.33%
8/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.42%
10/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.38%
9/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.25%
6/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.21%
5/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.25%
6/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.17%
4/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.13%
3/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.13%
3/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Colitis
|
0.13%
3/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Gastritis
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Ascites
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Constipation
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Enteritis
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Nausea
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Retroperitoneal mass
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Stomatitis
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Melaena
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Oral pain
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Tooth socket haemorrhage
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Syncope
|
1.0%
24/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.67%
16/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.38%
9/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.38%
9/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Dizziness
|
0.25%
6/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Presyncope
|
0.17%
4/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Convulsion
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Headache
|
0.13%
3/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Dysarthria
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Dementia
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Encephalopathy
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Hemiparesis
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Migraine
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Aphasia
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Clonus
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Lethargy
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Neuromyopathy
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Paresis
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Radicular pain
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Radiculopathy
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
General disorders
Chest pain
|
3.2%
76/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
2.8%
67/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
General disorders
Non-cardiac chest pain
|
0.33%
8/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
General disorders
Chest discomfort
|
0.17%
4/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
General disorders
Pyrexia
|
0.13%
3/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
General disorders
Oedema peripheral
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.17%
4/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
General disorders
Asthenia
|
0.13%
3/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
General disorders
Adverse event
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
General disorders
Device malfunction
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
General disorders
Fatigue
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
General disorders
Malaise
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
General disorders
Medical device complication
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
General disorders
Oedema
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
General disorders
Organ failure
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
General disorders
Swelling
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
General disorders
Ulcer haemorrhage
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.42%
10/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.46%
11/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Hospitalisation
|
0.17%
4/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.25%
6/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.25%
6/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Surgery
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.29%
7/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Spinal laminectomy
|
0.13%
3/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.17%
4/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Gastrectomy
|
0.13%
3/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.13%
3/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.17%
4/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Hip surgery
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Knee operation
|
0.13%
3/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Toe amputation
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Cardiac ablation
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Carotid endarterectomy
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Gallbladder operation
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Joint arthroplasty
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Shoulder arthroplasty
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Aortic valve replacement
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Cardioversion
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Colectomy
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Gastric bypass
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Intervertebral disc operation
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Mitral valve repair
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Nephrectomy
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Penile prosthesis insertion
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Shoulder operation
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Stent placement
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Tooth extraction
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Abdominal hernia repair
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Ankle operation
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Aortic aneurysm repair
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Appendicectomy
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Bladder neoplasm surgery
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Cancer surgery
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Cardiac pacemaker battery replacement
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Cataract operation
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Central venous catheterisation
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Craniotomy
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Finger amputation
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Fistula repair
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Foot amputation
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Hernia repair
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Implantable defibrillator replacement
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Intestinal resection
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Lung lobectomy
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Mastectomy
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Oesophagectomy
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Oesophagogastric fundoplasty
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Partial lung resection
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Pelvic floor repair
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Prolapse repair
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Prostatectomy
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Radical cystectomy
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Radiotherapy
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Removal of internal fixation
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Retinopexy
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Small intestinal resection
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Spinal cord operation
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Spinal fusion surgery
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Thyroidectomy
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Urinary cystectomy
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.29%
7/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.54%
13/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.29%
7/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.21%
5/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.13%
3/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.17%
4/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.21%
5/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.21%
5/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.13%
3/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.17%
4/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Of The Prostate
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal & Squamous Cell Carcinoma's Discovered
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Cancer
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Branchogenic Adenocarcinoma/Right Upper Lobectomy And M
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cytopathology Diagnosis Of Aus/Flus Or Follicular Hurth
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diagnosed With Non Basal Cell Malignancy
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diagnosis Of Bladder Cancer, Highly Invasive, With Live
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Essential thrombocythaemia
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive Squamous Cell Carcinoma (Right Cheek)
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Left Descending Colon Cancer
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Left Ureteropelvic Junction, Papillary Urothelial Carci
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lesion, Mid-Parietal Scalp, Squamous Cell Carcinoma
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver Cancer
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Bladder Polyps
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Spindle Cell Neoplasm
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Transitional Cell Cancer Of The Bladder
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Liver Cancer
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Micrometastatic Disease Melanoma
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
New Lung Cancer Diagnosis
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary Urothelial Carcinoma
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritoneal Carcinomatosis From A Low-Grade Mucinous Tum
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pt Newly Diagnosed With Stage 4 Cancer
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Recurrent Bladder Tumor
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Recurrent Bladder Tumor: Papillary Lesion , Proximal An
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Relapsed Non-Hodgkins Lymphoma
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Reported Diagnosis Lymphoma On Passive Follow Up
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Right Parietal Craniotomy For Benign Neoplasm Of Brain
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ruptured Mucinous Neoplasm Of The Appendix With Periton
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Biopsy- Possible Lymphoma
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sqamous Cell Carcinoma In Situ, Bowenoid Type
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Stage Ii Adenocarcinoma Of The Ascending Colon
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Stage Iv T2n0m1 Adenocarcinoma Of Theh Ead And Tail Of
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat cancer
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment For Metastasized Clear Cell Renal Cell Carcin
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Angina unstable
|
0.50%
12/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.79%
19/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Angina pectoris
|
0.50%
12/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.25%
6/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Bradycardia
|
0.21%
5/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.29%
7/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.17%
4/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Atrial fibrillation
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Atrial flutter
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.13%
3/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Arrhythmia
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Cardiac failure
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Coronary artery dissection
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Mitral valve disease
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Pericardial effusion
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Vascular disorders
Aortic aneurysm
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Pneumopericardium
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Sinus tachycardia
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.54%
13/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.50%
12/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.38%
9/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.38%
9/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.29%
7/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.17%
4/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.17%
4/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.17%
4/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Renal and urinary disorders
Renal failure acute
|
0.71%
17/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.88%
21/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Renal and urinary disorders
Haematuria
|
0.17%
4/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.17%
4/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Renal and urinary disorders
Renal failure
|
0.13%
3/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.13%
3/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Renal and urinary disorders
Renal mass
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Renal and urinary disorders
Urinary retention
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Renal and urinary disorders
Polyuria
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Blood glucose increased
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.21%
5/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Catheterisation cardiac
|
0.25%
6/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Arteriogram coronary
|
0.13%
3/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Liver function test abnormal
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
White blood cell count decreased
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Biopsy bladder
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Stress echocardiogram abnormal
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Alanine aminotransferase increased
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Aspiration pleural cavity
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Biopsy breast
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Biopsy liver
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Biopsy lung
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Blood creatinine increased
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Blood glucose decreased
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Blood pressure increased
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Blood urine present
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Bronchoscopy
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Cardiac stress test abnormal
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Cystoscopy
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Haemoglobin increased
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Hepatic enzyme increased
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Hepatitis C virus test positive
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Lipase increased
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Platelet count decreased
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Prostatic specific antigen increased
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Shift to the right
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Transaminases increased
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Troponin increased
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Weight decreased
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Weight increased
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
White blood cell count increased
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Fall
|
0.13%
3/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.21%
5/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.17%
4/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Spinal cord injury
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Testicular injury
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Traumatic arthropathy
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Wound
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.29%
7/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.17%
4/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.13%
3/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Metabolism and nutrition disorders
Obesity
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.21%
5/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.13%
3/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.13%
3/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Musculoskeletal and connective tissue disorders
Osteitis deformans
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue mass
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.29%
7/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.38%
9/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Blood and lymphatic system disorders
Leukopenia (AE & Lab Combined)
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Blood and lymphatic system disorders
Thrombocytopenia (AE & Lab Combined)
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Blood and lymphatic system disorders
Leukoerythroblastic anaemia
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Blood and lymphatic system disorders
Neutropenia (AE & Lab Combined)
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Blood and lymphatic system disorders
White blood cell disorder
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Vascular disorders
Hypotension
|
0.33%
8/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Vascular disorders
Hypertension
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Vascular disorders
Orthostatic hypotension
|
0.17%
4/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Vascular disorders
Aneurysm
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Vascular disorders
Aortic stenosis
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Vascular disorders
Hypertensive crisis
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Hepatobiliary disorders
Cholangitis
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Hepatobiliary disorders
Pneumobilia
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Psychiatric disorders
Mental status changes
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.17%
4/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Psychiatric disorders
Confusional state
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Psychiatric disorders
Depression
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.08%
2/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.08%
2/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Skin and subcutaneous tissue disorders
Cutaneous lupus erythematosus
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Eye disorders
Retinal detachment
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Eye disorders
Eye pain
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Eye disorders
Glaucoma
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Eye disorders
Retinal haemorrhage
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Eye disorders
Visual impairment
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.13%
3/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.04%
1/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.00%
0/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.04%
1/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Any Cancer
|
4.4%
106/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
4.0%
95/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-basal-cell skin cancer (not known if SAE)
|
1.4%
33/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
0.50%
12/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
Other adverse events
| Measure |
Methotrexate
n=2391 participants at risk
Methotrexate: Tablet, Oral, Target dose 15-20 mg weekly plus 1.0 mg folic acid 6 days/week
|
Placebo
n=2395 participants at risk
Placebo: Tablet, Oral, weekly plus 1.0 mg folic acid 6 days/week
|
|---|---|---|
|
Infections and infestations
Any
|
27.6%
659/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
24.4%
584/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Gastrointestinal disorders
Any
|
14.6%
350/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
11.9%
284/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Blood and lymphatic system disorders
Any
|
14.2%
340/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
10.2%
244/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
General disorders
Any
|
11.7%
279/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
10.6%
254/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Respiratory, thoracic and mediastinal disorders
Any
|
11.7%
279/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
8.8%
210/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Musculoskeletal and connective tissue disorders
Any
|
9.3%
223/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
9.6%
230/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Investigations
Any
|
9.2%
220/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
8.8%
211/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Nervous system disorders
Any
|
8.9%
213/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
8.1%
195/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Injury, poisoning and procedural complications
Any
|
6.3%
150/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
6.8%
163/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Surgical and medical procedures
Any
|
5.7%
137/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
6.1%
147/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Any
|
5.2%
124/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
4.2%
101/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Skin and subcutaneous tissue disorders
Any
|
4.1%
97/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
5.1%
121/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.1%
241/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
7.2%
172/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
|
General disorders
Chest pain
|
5.3%
126/2391 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
5.9%
142/2395 • From randomization to the trial end (April 2, 2018) - up to 5 years.
Pre-specified adverse events were collected via questions on the case report forms (CRFs) at each visit. Sites queried participants about any other adverse events and recorded them using a standard adverse event form that included the seriousness, relatedness, severity and outcomes. Those adverse events were MedDRA coded.
|
Additional Information
Dr. Paul Ridker and Dr. Robert Glynn
Brigham & Women's Hospital
Phone: 617-732-4965
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place