Trial Outcomes & Findings for Treatment of HDL to Reduce the Incidence of Vascular Events HPS2-THRIVE (NCT NCT00461630)
NCT ID: NCT00461630
Last Updated: 2014-02-28
Results Overview
Non-fatal myocardial infarction or coronary death, non-fatal or fatal stroke, or revascularisation
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
25673 participants
Primary outcome timeframe
During scheduled treatment period (median duration 3.9 years)
Results posted on
2014-02-28
Participant Flow
245 sites January 2007 to July 2010
Prior to randomization, each participant received simvastatin 40mg daily; if this dose was not as effective as their prior statin treatment or their total cholesterol was ≥135 mg/dl after 4 weeks on simvastatin alone, ezetimibe 10mg daily was added. Participants then received ERN/LRPT 1g/20mg daily for 4 weeks followed by 2g/40mg daily for 4 weeks.
Participant milestones
| Measure |
ER Niacin/Laropiprant
I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
|
Placebo
Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
|
|---|---|---|
|
Overall Study
STARTED
|
12838
|
12835
|
|
Overall Study
COMPLETED
|
11932
|
12008
|
|
Overall Study
NOT COMPLETED
|
906
|
827
|
Reasons for withdrawal
| Measure |
ER Niacin/Laropiprant
I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
|
Placebo
Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
|
|---|---|---|
|
Overall Study
Death
|
798
|
732
|
|
Overall Study
Lost to Follow-up
|
108
|
95
|
Baseline Characteristics
Treatment of HDL to Reduce the Incidence of Vascular Events HPS2-THRIVE
Baseline characteristics by cohort
| Measure |
ER Niacin/Laropiprant
n=12838 Participants
I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
|
Placebo
n=12835 Participants
Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
|
Total
n=25673 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6470 Participants
n=5 Participants
|
6462 Participants
n=7 Participants
|
12932 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6368 Participants
n=5 Participants
|
6373 Participants
n=7 Participants
|
12741 Participants
n=5 Participants
|
|
Age, Continuous
Age
|
64.9 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
64.9 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
64.9 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2224 Participants
n=5 Participants
|
2220 Participants
n=7 Participants
|
4444 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10614 Participants
n=5 Participants
|
10615 Participants
n=7 Participants
|
21229 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
5464 participants
n=5 Participants
|
5468 participants
n=7 Participants
|
10932 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
7374 participants
n=5 Participants
|
7367 participants
n=7 Participants
|
14741 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During scheduled treatment period (median duration 3.9 years)Non-fatal myocardial infarction or coronary death, non-fatal or fatal stroke, or revascularisation
Outcome measures
| Measure |
ER Niacin/Laropiprant
n=12838 Participants
I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
|
Placebo
n=12835 Participants
Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
|
|---|---|---|
|
Major Vascular Event
|
1696 participants
|
1758 participants
|
SECONDARY outcome
Timeframe: During scheduled treatment period (median duration 3.9 years)Non-fatal myocardial infarction (MI) or coronary death
Outcome measures
| Measure |
ER Niacin/Laropiprant
n=12838 Participants
I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
|
Placebo
n=12835 Participants
Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
|
|---|---|---|
|
Major Coronary Events
|
668 participants
|
694 participants
|
SECONDARY outcome
Timeframe: During scheduled treatment period (median duration 3.9 years)Fatal or non-fatal
Outcome measures
| Measure |
ER Niacin/Laropiprant
n=12838 Participants
I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
|
Placebo
n=12835 Participants
Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
|
|---|---|---|
|
Stroke
|
498 participants
|
499 participants
|
SECONDARY outcome
Timeframe: During scheduled treatment period (median duration 3.9 years)Outcome measures
| Measure |
ER Niacin/Laropiprant
n=12838 Participants
I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
|
Placebo
n=12835 Participants
Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
|
|---|---|---|
|
Coronary or Non-coronary Revascularisation
|
807 participants
|
897 participants
|
SECONDARY outcome
Timeframe: During scheduled treatment period (median duration 3.9 years)All-cause mortality
Outcome measures
| Measure |
ER Niacin/Laropiprant
n=12838 Participants
I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
|
Placebo
n=12835 Participants
Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
|
|---|---|---|
|
Mortality
|
798 participants
|
732 participants
|
Adverse Events
ER Niacin/Laropiprant
Serious events: 7137 serious events
Other events: 4248 other events
Deaths: 0 deaths
Placebo
Serious events: 6762 serious events
Other events: 2238 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ER Niacin/Laropiprant
n=12838 participants at risk
I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
|
Placebo
n=12835 participants at risk
Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
0.65%
84/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
0.44%
56/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Cardiac disorders
Cardiac disorders
|
15.1%
1937/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
15.0%
1925/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Congenital, familial and genetic disorders
Congenital, familial, genetic disorders
|
0.22%
28/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
0.15%
19/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders
|
0.41%
52/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
0.31%
40/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Eye disorders
Eye disorders
|
0.39%
50/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
0.58%
75/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
4.8%
620/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
3.8%
491/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
General disorders
General disorders
|
2.7%
346/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
2.3%
300/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
1.3%
163/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
1.1%
140/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Immune system disorders
Immune system disorders
|
0.16%
20/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
0.19%
25/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Infections and infestations
Infections and infestations
|
8.0%
1031/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
6.6%
853/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
3.6%
456/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
3.1%
400/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Investigations
Investigations
|
9.4%
1210/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
8.6%
1108/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
7.5%
961/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
5.5%
703/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
3.5%
446/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
2.8%
364/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
5.8%
751/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
5.8%
749/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Nervous system disorders
Nervous system disorders
|
8.3%
1067/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
8.5%
1086/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Psychiatric disorders
Psychiatric disorders
|
0.53%
68/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
0.51%
65/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
1.6%
208/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
1.5%
188/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
0.32%
41/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
0.31%
40/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
2.8%
358/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
2.4%
307/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
0.67%
86/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
0.40%
51/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Social circumstances
Social circumstances
|
0.00%
0/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
0.01%
1/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Surgical and medical procedures
Surgical and medical procedures
|
21.2%
2721/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
21.2%
2722/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Vascular disorders
Vascular disorders
|
2.0%
258/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
1.9%
246/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
Other adverse events
| Measure |
ER Niacin/Laropiprant
n=12838 participants at risk
I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
|
Placebo
n=12835 participants at risk
Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
|
|---|---|---|
|
Cardiac disorders
Cardiac disorders
|
0.27%
35/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
0.10%
13/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders
|
0.02%
3/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
0.01%
1/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Eye disorders
Eye disorders
|
0.37%
48/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
0.21%
27/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
9.1%
1168/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
5.4%
690/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
General disorders
General disorders
|
1.4%
176/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
1.1%
138/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Investigations
Investigations
|
1.7%
218/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
1.0%
132/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
3.4%
439/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
2.1%
270/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
4.2%
545/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
4.0%
516/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Nervous system disorders
Nervous system disorders
|
1.7%
213/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
1.4%
179/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Psychiatric disorders
Psychiatric disorders
|
0.87%
112/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
0.64%
82/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
0.33%
42/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
0.30%
38/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
0.00%
0/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
0.02%
2/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
0.58%
75/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
0.40%
51/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
14.3%
1835/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
4.5%
580/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
|
Vascular disorders
Vascular disorders
|
7.2%
927/12838 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
0.96%
123/12835 • Mean 3.6 year follow-up
Adverse Events were analyzed at the System Organ Class (SOC) level. All Serious Adverse Events were recorded, but non-serious adverse events were only recorded if considered by participant to be related to study treatment.
|
Additional Information
Professor Jane Armitage
Clinical Trial Service Unit, University of Oxford
Phone: +44 (0)1865 743743
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place