Trial Outcomes & Findings for Esomeprazole (NEXIUM) vs. Surgery (NCT NCT00251927)
NCT ID: NCT00251927
Last Updated: 2012-08-08
Results Overview
Treatment failure in the surgical arm defined when need for medical treatment for control of symptoms from reflux disease. Treatment failure in the medical arm defined when need for treatment other than esomeprazole for control of symptoms of reflux disease.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
626 participants
Primary outcome timeframe
During 5 years
Results posted on
2012-08-08
Participant Flow
The first patient was enrolled on 16 October 2001. Last patient completed the last visit on 07 April 2009.
The study started with a 12-week run-in period. Patients had either been treated or untreated with a proton pump inhibitor (PPI) prior to entering this phase of the study.
Participant milestones
| Measure |
Esomeprazole Surgical Arm
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
|
Esomeprazole Medical Arm
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
|
|---|---|---|
|
Overall Study
STARTED
|
288
|
266
|
|
Overall Study
COMPLETED
|
180
|
192
|
|
Overall Study
NOT COMPLETED
|
108
|
74
|
Reasons for withdrawal
| Measure |
Esomeprazole Surgical Arm
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
|
Esomeprazole Medical Arm
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
15
|
|
Overall Study
Lack of Efficacy
|
22
|
16
|
|
Overall Study
Lost to Follow-up
|
22
|
8
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Pregnancy
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
40
|
25
|
|
Overall Study
Study-specific discont. achieved
|
13
|
2
|
|
Overall Study
Study procedure non-compliance
|
5
|
6
|
Baseline Characteristics
Esomeprazole (NEXIUM) vs. Surgery
Baseline characteristics by cohort
| Measure |
Esomeprazole Surgical Arm
n=288 Participants
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
|
Esomeprazole Medical Arm
n=266 Participants
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
|
Total
n=554 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
44.8 Years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
45.3 Years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
45.05 Years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
199 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
398 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During 5 yearsTreatment failure in the surgical arm defined when need for medical treatment for control of symptoms from reflux disease. Treatment failure in the medical arm defined when need for treatment other than esomeprazole for control of symptoms of reflux disease.
Outcome measures
| Measure |
Esomeprazole Surgical Arm
n=288 Participants
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
|
Esomeprazole Medical Arm
n=266 Participants
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
|
|---|---|---|
|
Number of Participants With Treatment Failure at 5 Years
|
33 participants
|
19 participants
|
SECONDARY outcome
Timeframe: At 5 year visitEndoscopic findings classified according to the Los Angeles classification: Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks \<5 mm in maximal length Grade B - one or more mucosal breaks \>5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between \>2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference
Outcome measures
| Measure |
Esomeprazole Surgical Arm
n=288 Participants
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
|
Esomeprazole Medical Arm
n=266 Participants
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
|
|---|---|---|
|
Los Angeles (LA) Grade 'Normal' at 5 Year Visit
|
144 participants
|
158 participants
|
SECONDARY outcome
Timeframe: At 5 year visitPresence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe) Participants with no heartburn
Outcome measures
| Measure |
Esomeprazole Surgical Arm
n=288 Participants
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
|
Esomeprazole Medical Arm
n=266 Participants
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
|
|---|---|---|
|
Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With no Heartburn
|
163 participants
|
161 participants
|
SECONDARY outcome
Timeframe: At 5 year visitThe total score expressed as a mean of all the scores/number of lesions assessed; scored 2 when erosion/necrosis is found. The score could range from 0 to 2 (maximum severity). Only participants with biopsy at 5 years visit included
Outcome measures
| Measure |
Esomeprazole Surgical Arm
n=153 Participants
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
|
Esomeprazole Medical Arm
n=177 Participants
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
|
|---|---|---|
|
Total Score for Microscopic Reflux-related Changes in the Distal Esophagus 2 cm Above the Z-line, at 5 Year Visit
|
0.23 units on a scale
Standard Error 0.10
|
0.25 units on a scale
Standard Error 0.03
|
SECONDARY outcome
Timeframe: At 5 year visitIntra-gastric acid exposures assessed by 24-h pH-metry. Only participants with pH-emtry performed at 5 year visit included
Outcome measures
| Measure |
Esomeprazole Surgical Arm
n=124 Participants
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
|
Esomeprazole Medical Arm
n=162 Participants
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
|
|---|---|---|
|
Percentage Time With pH<4 During 24-hour pH Metry at 5 Year Visit
|
2.9 percentage of time recorded
Standard Deviation 7.0
|
4.7 percentage of time recorded
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: At 5 year visitEndoscopic findings classified according to the Los Angeles classification: Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks \<5 mm in maximal length Grade B - one or more mucosal breaks \>5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between \>2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference
Outcome measures
| Measure |
Esomeprazole Surgical Arm
n=288 Participants
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
|
Esomeprazole Medical Arm
n=266 Participants
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
|
|---|---|---|
|
Los Angeles (LA) Grade 'A' at 5 Year Visit
|
12 participants
|
16 participants
|
SECONDARY outcome
Timeframe: At 5 year visitEndoscopic findings classified according to the Los Angeles classification: Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks \<5 mm in maximal length Grade B - one or more mucosal breaks \>5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between \>2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference
Outcome measures
| Measure |
Esomeprazole Surgical Arm
n=288 Participants
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
|
Esomeprazole Medical Arm
n=266 Participants
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
|
|---|---|---|
|
Los Angeles (LA) Grade 'B' at 5 Year Visit
|
5 participants
|
7 participants
|
SECONDARY outcome
Timeframe: At 5 year visitEndoscopic findings classified according to the Los Angeles classification: Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks \<5 mm in maximal length Grade B - one or more mucosal breaks \>5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between \>2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference
Outcome measures
| Measure |
Esomeprazole Surgical Arm
n=288 Participants
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
|
Esomeprazole Medical Arm
n=266 Participants
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
|
|---|---|---|
|
Los Angeles (LA) Grade C at 5 Year Visit
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: At 5 year visitPresence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with mild heartburn
Outcome measures
| Measure |
Esomeprazole Surgical Arm
n=288 Participants
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
|
Esomeprazole Medical Arm
n=266 Participants
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
|
|---|---|---|
|
Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Mild Heartburn
|
11 participants
|
25 participants
|
SECONDARY outcome
Timeframe: At 5 year visitPresence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with moderate heartburn
Outcome measures
| Measure |
Esomeprazole Surgical Arm
n=288 Participants
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
|
Esomeprazole Medical Arm
n=266 Participants
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
|
|---|---|---|
|
Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Moderate Heartburn
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: At 5 year visitPresence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with severe heartburn
Outcome measures
| Measure |
Esomeprazole Surgical Arm
n=288 Participants
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
|
Esomeprazole Medical Arm
n=266 Participants
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
|
|---|---|---|
|
Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Severe Heartburn
|
0 participants
|
2 participants
|
Adverse Events
Esomeprazole Surgical Arm
Serious events: 103 serious events
Other events: 0 other events
Deaths: 0 deaths
Esomeprazole Medical Arm
Serious events: 101 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Surgical Arm
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Esomeprazole Surgical Arm
n=248 participants at risk
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
|
Esomeprazole Medical Arm
n=266 participants at risk
Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
|
Non-Surgical Arm
n=40 participants at risk
This group of patients was randomized to receive surgery but were on operated on and were followed for safety purposes
|
|---|---|---|---|
|
Gastrointestinal disorders
Mallory-Weiss Syndrome
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Gastrointestinal disorders
Subileus
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Gastrointestinal disorders
Chest Discomfort
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
General disorders
Dysplasia
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Blood and lymphatic system disorders
Microcytic Anaemia
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/248
|
0.75%
2/266
|
0.00%
0/40
|
|
Cardiac disorders
Angina Pectoris
|
0.40%
1/248
|
1.1%
3/266
|
0.00%
0/40
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Cardiac disorders
Arteriosclerosis Coronary Artery
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/248
|
0.38%
1/266
|
2.5%
1/40
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Cardiac disorders
Coronary Artery Disease
|
0.81%
2/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Cardiac disorders
Myocardial Infarction
|
0.81%
2/248
|
1.1%
3/266
|
0.00%
0/40
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Cardiac disorders
Palpitations
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Cardiac disorders
Pericarditis
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Cardiac disorders
Sinus Tachycardia
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Ear and labyrinth disorders
Conductive Deafness
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Eye disorders
Cataract
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Eye disorders
Corneal Oedema
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Eye disorders
Glaucoma
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Eye disorders
Keratitis
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Eye disorders
Retinal Vein Occlusion
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.81%
2/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.40%
1/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Gastrointestinal disorders
Acute Abdomen
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Gastrointestinal disorders
Barrett's Oesophagus
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Gastrointestinal disorders
Colonic Pseudo-Obstruction
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Gastrointestinal disorders
Constipation
|
0.40%
1/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Gastrointestinal disorders
Diverticulitis Intestinal Haemorrhagic
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Gastrointestinal disorders
Dysphagia
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Gastrointestinal disorders
Gastric Perforation
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Gastrointestinal disorders
Gastric Ulcer Perforation
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Gastrointestinal disorders
Gastritis Haemorrhagic
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Gastrointestinal disorders
Gastrointestinal Motility Disorder
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.40%
1/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Gastrointestinal disorders
Ileus
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Gastrointestinal disorders
Ileus Paralytic
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Gastrointestinal disorders
Impaired Gastric Emptying
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Gastrointestinal disorders
Lumbar Hernia
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
General disorders
Multi-Organ Failure
|
0.00%
0/248
|
0.00%
0/266
|
0.00%
0/40
|
|
General disorders
Non-Cardiac Chest Pain
|
1.2%
3/248
|
1.9%
5/266
|
0.00%
0/40
|
|
General disorders
Oedema Peripheral
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
General disorders
Pyrexia
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Hepatobiliary disorders
Bile Duct Stenosis
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Hepatobiliary disorders
Cholecystitis
|
0.40%
1/248
|
0.75%
2/266
|
2.5%
1/40
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.2%
3/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Infections and infestations
Abscess Jaw
|
0.00%
0/248
|
0.00%
0/266
|
2.5%
1/40
|
|
Infections and infestations
Appendicitis
|
0.40%
1/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/248
|
0.75%
2/266
|
0.00%
0/40
|
|
Infections and infestations
Erysipelas
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Infections and infestations
Gastroenteritis
|
0.40%
1/248
|
1.1%
3/266
|
0.00%
0/40
|
|
Infections and infestations
Pneumonia
|
0.00%
0/248
|
0.75%
2/266
|
0.00%
0/40
|
|
Infections and infestations
Pneumonia Primary Atypical
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Infections and infestations
Sepsis
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Infections and infestations
Tubo-Ovarian Abscess
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Infections and infestations
Urinary Tract Infection
|
0.81%
2/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Complication Of Device Insertion
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Gas Poisoning
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
1.2%
3/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Meniscus Lesion
|
0.40%
1/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Operative Haemorrhage
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Overdose
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Patella Fracture
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.00%
0/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Post Procedural Complication
|
1.6%
4/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Procedural Complication
|
0.81%
2/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
1.2%
3/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Skull Fracture
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Traumatic Brain Injury
|
0.00%
0/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Urinary Bladder Rupture
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
0.00%
0/248
|
0.75%
2/266
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.40%
1/248
|
0.75%
2/266
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Foot Deformity
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.40%
1/248
|
1.5%
4/266
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.6%
4/248
|
0.75%
2/266
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Pancreas
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm Of Thyroid Gland
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Peritoneal Neoplasm
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid Tumour Pulmonary
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic Lymphocytic Leukaemia
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.00%
0/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Of Spermatic Cord
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple Myeloma
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.40%
1/248
|
0.75%
2/266
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seminoma
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue Neoplasm
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.81%
2/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Nervous system disorders
Headache
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Nervous system disorders
Sciatica
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Psychiatric disorders
Anxiety Disorder
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Psychiatric disorders
Depression
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Psychiatric disorders
Suicide Attempt
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Renal and urinary disorders
Calculus Ureteric
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.40%
1/248
|
0.75%
2/266
|
0.00%
0/40
|
|
Reproductive system and breast disorders
Epididymitis
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Reproductive system and breast disorders
Ovarian Torsion
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Reproductive system and breast disorders
Uterine Polyp
|
0.40%
1/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Reproductive system and breast disorders
Vaginal Prolapse
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Suffocation Feeling
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
Vocal Cord Cyst
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Skin and subcutaneous tissue disorders
Skin Fissures
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Vascular disorders
Aortic Aneurysm
|
0.00%
0/248
|
0.75%
2/266
|
0.00%
0/40
|
|
Vascular disorders
Arterial Thrombosis Limb
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Vascular disorders
Arteriosclerosis
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Vascular disorders
Embolism
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Vascular disorders
Hypertension
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Vascular disorders
Necrosis Ischaemic
|
0.00%
0/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.40%
1/248
|
0.38%
1/266
|
0.00%
0/40
|
|
Vascular disorders
Varicose Vein
|
0.40%
1/248
|
0.00%
0/266
|
0.00%
0/40
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place