Combination Chemotherapy With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for High Risk Stage II or Stage III Colon Cancer
This study has been completed.
Sponsor:
Hoffmann-La Roche
Collaborator:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00112918
First received: June 2, 2005
Last updated: August 6, 2012
Last verified: August 2012
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Results First Received: June 1, 2012
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Colorectal Cancer |
| Interventions: |
Biological: Bevacizumab Drug: Capecitabine Drug: 5-Fluorouracil (5-FU) Drug: Leucovorin calcium Drug: Oxaliplatin |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Randomization was stratified according to geographic region and disease stage (high-risk stage II or stage III N1 or stage III N2). The primary analysis population consisted of patients with Stage III disease. |
Reporting Groups
| Description | |
|---|---|
| FOLFOX4 |
Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-fluorouracil (5-FU), given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Observation only. |
| FOLFOX4 + Bv |
Weeks 1–24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks). |
| XELOX+Bv |
Weeks 1–24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks). Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks). |
Participant Flow: Overall Study
| FOLFOX4 | FOLFOX4 + Bv | XELOX+Bv | |
|---|---|---|---|
| STARTED | 1151 | 1155 | 1145 |
| Received Treatment | 1126 | 1145 [1] | 1135 |
| Stage III Disease Population | 955 | 960 | 952 |
| COMPLETED | 937 [2] | 917 [2] | 916 [2] |
| NOT COMPLETED | 214 | 238 | 229 |
| [1] | Includes two patients from FOLFOX4 who received Bv and were assigned to FOLFOX4+Bv safety analysis |
|---|---|
| [2] | Represents patients alive in follow-up at the time of data cut-off (30 June 2010) |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| FOLFOX4 |
Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-fluorouracil (5-FU), given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Observation only. |
| FOLFOX4 + Bv |
Weeks 1–24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks). |
| XELOX+Bv |
Weeks 1–24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks). Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks). |
| Total | Total of all reporting groups |
Baseline Measures
| FOLFOX4 | FOLFOX4 + Bv | XELOX+Bv | Total | |
|---|---|---|---|---|
|
Number of Participants
[units: participants] |
955 | 960 | 952 | 2867 |
|
Age, Customized
[1] [units: participants] |
||||
| <40 | 77 | 74 | 68 | 219 |
| 40-65 | 603 | 625 | 588 | 1816 |
| >=65 | 275 | 261 | 296 | 832 |
|
Gender
[units: participants] |
||||
| Female | 425 | 473 | 432 | 1330 |
| Male | 530 | 487 | 520 | 1537 |
|
Race/Ethnicity, Customized
[units: participants] |
||||
| American Indian or Alaska Native | 1 | 1 | 0 | 2 |
| Asian | 139 | 115 | 123 | 377 |
| Black or African American | 6 | 13 | 14 | 33 |
| White | 791 | 813 | 795 | 2399 |
| Other | 18 | 18 | 20 | 56 |
| [1] | Baseline Measures are based on the Intent-to-Treat - Stage III Disease Patient Population. |
|---|
Outcome Measures
| 1. Primary: | Disease-free Survival in Stage III Cancer Patients - Time to Event [ Time Frame: From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized). ] |
| 2. Primary: | Disease-free Survival in Stage III Cancer Patients - Number of Events [ Time Frame: From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized). ] |
| 3. Secondary: | Overall Survival in Stage III Cancer Patients - Time to Event [ Time Frame: From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized). ] |
| 4. Secondary: | Overall Survival in Stage III Cancer Patients - Number of Events [ Time Frame: From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized). ] |
Serious Adverse Events| Time Frame | All adverse events occurring between the date of first drug intake and 28 days after last drug intake, regardless of which treatment group the patient was randomized to. |
|---|---|
| Additional Description | No text entered. |
Reporting Groups
| Description | |
|---|---|
| FOLFOX4 |
Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with Leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Observation only. |
| FOLFOX4 + Bv |
Weeks 1–24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks). |
| XELOX+Bv |
Weeks 1–24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks). Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks). |
Serious Adverse Events
| FOLFOX4 | FOLFOX4 + Bv | XELOX+Bv | |
|---|---|---|---|
| Total, serious adverse events | |||
| # participants affected / at risk | 226/1126 (20.07%) | 297/1145 (25.94%) | 284/1135 (25.02%) |
| Blood and lymphatic system disorders | |||
| Neutropenia † 1 | |||
| # participants affected / at risk | 18/1126 (1.60%) | 18/1145 (1.57%) | 0/1135 (0.00%) |
| Febrile neutropenia † 1 | |||
| # participants affected / at risk | 14/1126 (1.24%) | 9/1145 (0.79%) | 2/1135 (0.18%) |
| Anaemia † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Idiopathic thrombocytopenia purpura † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Leukopenia † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Thrombocytopenia † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Cardiac disorders | |||
| Myocardial infarction † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 5/1145 (0.44%) | 1/1135 (0.09%) |
| Angina pectoris † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 1/1145 (0.09%) | 4/1135 (0.35%) |
| Coronary artery disease † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 2/1145 (0.17%) | 1/1135 (0.09%) |
| Myocardial ischaemia † 1 | |||
| # participants affected / at risk | 2/1126 (0.18%) | 1/1145 (0.09%) | 1/1135 (0.09%) |
| Acute myocardial infarction † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 2/1145 (0.17%) | 0/1135 (0.00%) |
| Cardiac arrest † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 2/1135 (0.18%) |
| Angina unstable † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 1/1135 (0.09%) |
| Arteriospasm coronary † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Atrial fibrillation † 1 | |||
| # participants affected / at risk | 2/1126 (0.18%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Acute coronary syndrome † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Cardiac asthma † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Cardiac failure † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Cardiac failure congestive † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Left ventricular dysfunction † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Mitral valve incompetence † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Palpitations † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Paroxysmal arrhythmia † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Pericardial haemorrhage † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Sinus arrest † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Ear and labyrinth disorders | |||
| Vertigo † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Endocrine disorders | |||
| Hypothyroidism † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Eye disorders | |||
| Retinal detachment † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Retinal vein thrombosis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Uveitis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Gastrointestinal disorders | |||
| Diarrhoea † 1 | |||
| # participants affected / at risk | 28/1126 (2.49%) | 28/1145 (2.45%) | 62/1135 (5.46%) |
| Abdominal pain † 1 | |||
| # participants affected / at risk | 11/1126 (0.98%) | 14/1145 (1.22%) | 18/1135 (1.59%) |
| Vomiting † 1 | |||
| # participants affected / at risk | 7/1126 (0.62%) | 11/1145 (0.96%) | 16/1135 (1.41%) |
| Intestinal obstruction † 1 | |||
| # participants affected / at risk | 6/1126 (0.53%) | 9/1145 (0.79%) | 7/1135 (0.62%) |
| Nausea † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 4/1145 (0.35%) | 7/1135 (0.62%) |
| Rectal haemorrhage † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 7/1145 (0.61%) | 3/1135 (0.26%) |
| Enteritis † 1 | |||
| # participants affected / at risk | 3/1126 (0.27%) | 0/1145 (0.00%) | 5/1135 (0.44%) |
| Small intestinal obstruction † 1 | |||
| # participants affected / at risk | 2/1126 (0.18%) | 2/1145 (0.17%) | 4/1135 (0.35%) |
| Constipation † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 4/1145 (0.35%) | 2/1135 (0.18%) |
| Subileus † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 4/1145 (0.35%) | 2/1135 (0.18%) |
| Colitis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 5/1135 (0.44%) |
| Abdominal adhesions † 1 | |||
| # participants affected / at risk | 2/1126 (0.18%) | 0/1145 (0.00%) | 2/1135 (0.18%) |
| Gastritis † 1 | |||
| # participants affected / at risk | 3/1126 (0.27%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Gastrointestinal haemorrhage † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 2/1145 (0.17%) | 2/1135 (0.18%) |
| Gastrointestinal obstruction † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 3/1145 (0.26%) | 1/1135 (0.09%) |
| Haemorrhoids † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 1/1145 (0.09%) | 2/1135 (0.18%) |
| Oesophagitis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 2/1145 (0.17%) | 2/1135 (0.18%) |
| Small intestinal perforation † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 4/1145 (0.35%) | 0/1135 (0.00%) |
| Enterocolitis † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 1/1145 (0.09%) | 1/1135 (0.09%) |
| Ileus paralytic † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 2/1135 (0.18%) |
| Intestinal perforation † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 2/1145 (0.17%) | 0/1135 (0.00%) |
| Pancreatitis † 1 | |||
| # participants affected / at risk | 2/1126 (0.18%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Pancreatitis acute † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 1/1145 (0.09%) | 1/1135 (0.09%) |
| Peritonitis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 2/1135 (0.18%) |
| Stomatitis † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 2/1135 (0.18%) |
| Abdominal distension † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Abdominal hernia † 1 | |||
| # participants affected / at risk | 2/1126 (0.18%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Anal fissure † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Anal fistula † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 2/1145 (0.17%) | 0/1135 (0.00%) |
| Gastrointestinal necrosis † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Haematemesis † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Haematochezia † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 2/1135 (0.18%) |
| Ileus † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Mechanical ileus † 1 | |||
| # participants affected / at risk | 2/1126 (0.18%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Abdominal discomfort † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Abdominal pain lower † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Abdominal pain upper † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Abdominal rigidity † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Acute abdomen † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Caecitis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Colitis ulcerative † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Crohn's disease † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Duodenitis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Dyspepsia † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Enterocolitis haemorrhagic † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Erosive oesophagitis † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Faecaloma † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Food poisoning † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Gastric ulcer † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Gastric volvulus † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Gastrointestinal perforation † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Gastrooesophageal reflux disease † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Hiatus hernia, obstructive † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Ileal perforation † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Intestinal angina † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Intestinal dilatation † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Intestinal fistula † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Intestinal ischaemia † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Intestinal prolapse † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Intestinal strangulation † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Large intestine perforation † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Lower gastrointestinal haemorrhage † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Mallory-Weiss syndrome † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Melaena † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Mesenteric vein thrombosis † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Neutropenic colitis † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Rectal perforation † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Umbilical hernia † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Upper gastrointestinal haemorrhage † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Volvulus of small bowel † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| General disorders | |||
| Pyrexia † 1 | |||
| # participants affected / at risk | 20/1126 (1.78%) | 10/1145 (0.87%) | 16/1135 (1.41%) |
| Non-cardiac chest pain † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 2/1145 (0.17%) | 5/1135 (0.44%) |
| Sudden death † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 2/1145 (0.17%) | 3/1135 (0.26%) |
| Asthenia † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 3/1145 (0.26%) | 1/1135 (0.09%) |
| Chest pain † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 2/1145 (0.17%) | 1/1135 (0.09%) |
| Extravasation † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 2/1135 (0.18%) |
| Medical device complication † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Multi-organ failure † 1 | |||
| # participants affected / at risk | 2/1126 (0.18%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Thrombosis in device † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Adhesion † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Catheter site pain † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Chills † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Device leakage † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Device malfunction † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| General physical health deterioration † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Hernia obstructive † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Hyperpyrexia † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Infusion site thrombosis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Malaise † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Pain † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Performance status decreased † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Sudden cardiac death † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Visceral pain † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Hepatobiliary disorders | |||
| Cholecystitis † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 1/1145 (0.09%) | 2/1135 (0.18%) |
| Portal vein thrombosis † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 2/1145 (0.17%) | 1/1135 (0.09%) |
| Cholangitis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Cholecystitis acute † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Cholelithiasis † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Cytolytic hepatitis † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Hepatic function abnormal † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Hepatitis toxic † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Hepatotoxicity † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Hyperbilirubinaemia † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Immune system disorders | |||
| Drug hypersensitivity † 1 | |||
| # participants affected / at risk | 5/1126 (0.44%) | 3/1145 (0.26%) | 1/1135 (0.09%) |
| Hypersensitivity † 1 | |||
| # participants affected / at risk | 3/1126 (0.27%) | 1/1145 (0.09%) | 1/1135 (0.09%) |
| Anaphylactic reaction † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 3/1145 (0.26%) | 0/1135 (0.00%) |
| Anaphylactic shock † 1 | |||
| # participants affected / at risk | 2/1126 (0.18%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Anaphylactiod reaction † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Infections and infestations | |||
| Device related infection † 1 | |||
| # participants affected / at risk | 8/1126 (0.71%) | 12/1145 (1.05%) | 4/1135 (0.35%) |
| Pneumonia † 1 | |||
| # participants affected / at risk | 3/1126 (0.27%) | 4/1145 (0.35%) | 5/1135 (0.44%) |
| Urinary tract infection † 1 | |||
| # participants affected / at risk | 2/1126 (0.18%) | 5/1145 (0.44%) | 4/1135 (0.35%) |
| Sepsis † 1 | |||
| # participants affected / at risk | 4/1126 (0.36%) | 3/1145 (0.26%) | 3/1135 (0.26%) |
| Gastroenteritis † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 5/1145 (0.44%) | 3/1135 (0.26%) |
| Infection † 1 | |||
| # participants affected / at risk | 5/1126 (0.44%) | 3/1145 (0.26%) | 1/1135 (0.09%) |
| Abdominal abscess † 1 | |||
| # participants affected / at risk | 2/1126 (0.18%) | 4/1145 (0.35%) | 2/1135 (0.18%) |
| Catheter site infection † 1 | |||
| # participants affected / at risk | 4/1126 (0.36%) | 4/1145 (0.35%) | 0/1135 (0.00%) |
| Neutropenic sepsis † 1 | |||
| # participants affected / at risk | 4/1126 (0.36%) | 1/1145 (0.09%) | 1/1135 (0.09%) |
| Lower respiratory tract infection † 1 | |||
| # participants affected / at risk | 3/1126 (0.27%) | 2/1145 (0.17%) | 0/1135 (0.00%) |
| Anal abscess † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 3/1145 (0.26%) | 1/1135 (0.09%) |
| Cellulitis † 1 | |||
| # participants affected / at risk | 3/1126 (0.27%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Abdominal wall abscess † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 2/1145 (0.17%) | 1/1135 (0.09%) |
| Device related sepsis † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 1/1145 (0.09%) | 1/1135 (0.09%) |
| Staphylococcal sepsis † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 2/1135 (0.18%) |
| Abscess † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 2/1145 (0.17%) | 0/1135 (0.00%) |
| Erysipelas † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 1/1135 (0.09%) |
| Herpes zoster † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Neutropenic infection † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Pelvic abscess † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 2/1145 (0.17%) | 0/1135 (0.00%) |
| Septic shock † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 1/1135 (0.09%) |
| Upper respiratory tract infection † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 1/1135 (0.09%) |
| Viral infection † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 1/1135 (0.09%) |
| Abdominal infection † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Appendicitis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Appendicitis perforated † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Aspergillosis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Bacteraemia † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Bronchopneumonia † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Bronchopulmonary aspergillosis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Campylobacter infection † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Candida sepsis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Catheter site cellulitis † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Cholecystitis infective † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Clostridial infection † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Clostridium difficile colitis † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Diverticulitis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Enteritis infection † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Gastroenteritis norovirus † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Gastroenteritis viral † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Hepatitis viral † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Herpes zoster ophthalmic † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Incision site cellulitis † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Intervertebral discitis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Intestinal fistual infection † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Klebsiella bacteraemia † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Klebsiella infection † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Lower respiratory tract infection viral † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Oral candidiasis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Orchitis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Overgrowth bacterial † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Perineal abscess † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Pharyngitis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Post procedural infection † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Postoperative abscess † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Psoas abscess † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Puncture site infection † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Respiratory tract infection † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Skin infection † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Staphylococcal bacteraemia † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Subcutaneous abscess † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Tooth abscess † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Tuberculosis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Wound abscess † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Wound infection † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Injury, poisoning and procedural complications | |||
| Incisional hernia † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 2/1145 (0.17%) | 2/1135 (0.18%) |
| Procedural site reaction † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 2/1135 (0.18%) |
| Accident at work † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Anastomotic stenosis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Brachial plexus injury † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Cervical vertebral fracture † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Drug toxicity † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Fall † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Foot fracture † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Femur fracture † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Head injury † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Joint dislocation † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Multiple fractures † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Post procedural fistula † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Post procedural haemorrhage † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Road traffic accident † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Subdural haematoma † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Thoracic vertebral fracture † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Tibia fracture † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Investigations | |||
| Blood lactate dehydrogenase increased † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Blood creatinine increased † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Blood glucose fluctuation † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Weight increased † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Metabolism and nutrition disorders | |||
| Dehydration † 1 | |||
| # participants affected / at risk | 7/1126 (0.62%) | 10/1145 (0.87%) | 17/1135 (1.50%) |
| Hyperglycaemia † 1 | |||
| # participants affected / at risk | 3/1126 (0.27%) | 4/1145 (0.35%) | 2/1135 (0.18%) |
| Hypokalaemia † 1 | |||
| # participants affected / at risk | 2/1126 (0.18%) | 3/1145 (0.26%) | 2/1135 (0.18%) |
| Decreased appetite † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 2/1135 (0.18%) |
| Hypertriglyceridaemia † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 1/1135 (0.09%) |
| Hypocalcaemia † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 1/1135 (0.09%) |
| Hyponatraemia † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 2/1145 (0.17%) | 0/1135 (0.00%) |
| Diabetes mellitus † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Diabetic ketoacidosis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Gout † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Hypercholesterolaemia † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Hypomagnesaemia † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Musculoskeletal and connective tissue disorders | |||
| Musculoskeletal pain † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 1/1145 (0.09%) | 1/1135 (0.09%) |
| Intervertebral disc protusion † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Muscle spasms † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Muscular weakness † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Musculoskeletal chest pain † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Musculoskeletal disorder † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Myalgia † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Pain in extremity † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | |||
| Breast cancer † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Benign lung neoplasm † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Nervous system disorders | |||
| Syncope † 1 | |||
| # participants affected / at risk | 2/1126 (0.18%) | 5/1145 (0.44%) | 1/1135 (0.09%) |
| Transient ischaemic attack † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 3/1145 (0.26%) | 2/1135 (0.18%) |
| Cerebrovascular accident † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 2/1145 (0.17%) | 1/1135 (0.09%) |
| Neuropathy peripheral † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 1/1145 (0.09%) | 1/1135 (0.09%) |
| Convulsion † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Dizziness † 1 | |||
| # participants affected / at risk | 2/1126 (0.18%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Epilepsy † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 2/1135 (0.18%) |
| Headache † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 1/1135 (0.09%) |
| Ischaemic stroke † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 2/1135 (0.18%) |
| Peripheral sensory neuropathy † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 1/1135 (0.09%) |
| Cerebral ischaemia † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Dysaesthesia † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Encephalopathy † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Leukoaraiosis † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Loss of consciousness † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Migraine † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Monoparesis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Neurotoxicity † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Orthostatic intolerance † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Paraesthesia † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Post herpetic neuralgia † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Reversible ischaemic neurological deficit † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Reversible posterior leukoencephalopathy syndrome † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Sensory disturbance † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Somnolence † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Speech disorder † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Psychiatric disorders | |||
| Depression † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 1/1135 (0.09%) |
| Alcoholism † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Anxiety † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Renal and urinary disorders | |||
| Hydronephrosis † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 1/1145 (0.09%) | 1/1135 (0.09%) |
| Renal failure acute † 1 | |||
| # participants affected / at risk | 2/1126 (0.18%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Renal failure † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 1/1135 (0.09%) |
| Renal impairment † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 1/1135 (0.09%) |
| Ureteric stenosis † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Acute prerenal failure † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Calculus ureteric † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Calculus urinary † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Nephrogenic diabetes insipidus † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Nephrotic syndrome † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Reproductive system and breast disorders | |||
| Female genital tract fistula † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Prostatitis † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Vaginal haemorrhage † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Respiratory, thoracic and mediastinal disorders | |||
| Pulmonary embolism † 1 | |||
| # participants affected / at risk | 11/1126 (0.98%) | 15/1145 (1.31%) | 10/1135 (0.88%) |
| Dyspnoea † 1 | |||
| # participants affected / at risk | 2/1126 (0.18%) | 3/1145 (0.26%) | 2/1135 (0.18%) |
| Epistaxis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 3/1145 (0.26%) | 1/1135 (0.09%) |
| Bronchospasm † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 2/1135 (0.18%) |
| Dysaesthesia pharynx † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 3/1135 (0.26%) |
| Laryngospasm † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 3/1135 (0.26%) |
| Pneumothorax † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 2/1145 (0.17%) | 0/1135 (0.00%) |
| Respiratory failure † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 2/1135 (0.18%) |
| Acute respiratory distress syndrome † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Interstitial lung disease † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Organising pneumonia † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Pneumonia aspiration † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Pulmonary artery thrombosis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Pulmonary oedema † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Skin and subcutaneous tissue disorders | |||
| Angioedema † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Drug eruption † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Palmar-Plantar † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Swelling face † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Urticaria † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Social circumstances | |||
| Pregnancy of partner † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Surgical and medical procedures | |||
| Central venous catheter removal † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Vascular disorders | |||
| Deep vein thrombosis † 1 | |||
| # participants affected / at risk | 9/1126 (0.80%) | 16/1145 (1.40%) | 12/1135 (1.06%) |
| Hypertension † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 2/1145 (0.17%) | 13/1135 (1.15%) |
| Venous thrombosis † 1 | |||
| # participants affected / at risk | 3/1126 (0.27%) | 5/1145 (0.44%) | 1/1135 (0.09%) |
| Jugular vein thrombosis † 1 | |||
| # participants affected / at risk | 2/1126 (0.18%) | 3/1145 (0.26%) | 0/1135 (0.00%) |
| Subclavian vein thrombosis † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 2/1145 (0.17%) | 2/1135 (0.18%) |
| Venous thrombosis limb † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 3/1145 (0.26%) | 2/1135 (0.18%) |
| Hypertensive crisis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 3/1145 (0.26%) | 1/1135 (0.09%) |
| Hypotension † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 2/1145 (0.17%) | 1/1135 (0.09%) |
| Thrombophlebitis † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Thrombosis † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Arterial stenosis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Arterial thrombosis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Arterial thrombosis limb † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Axillary vein thrombosis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Pelvic venous thrombosis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 0/1145 (0.00%) | 1/1135 (0.09%) |
| Peripheral ischaemia † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| Phlebitis † 1 | |||
| # participants affected / at risk | 0/1126 (0.00%) | 1/1145 (0.09%) | 0/1135 (0.00%) |
| Thrombophlebitis superficial † 1 | |||
| # participants affected / at risk | 1/1126 (0.09%) | 0/1145 (0.00%) | 0/1135 (0.00%) |
| † | Events were collected by systematic assessment |
|---|---|
| 1 | Term from vocabulary, MedDRA (13.0) |
Other Adverse Events
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided by Hoffmann-La Roche
Publications automatically indexed to this study:
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590
Organization: Hoffman-LaRoche
phone: 800-821-8590
No publications provided by Hoffmann-La Roche
Publications automatically indexed to this study:
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00112918 History of Changes |
| Other Study ID Numbers: | CDR0000427299, P30CA016042, UCLA-0412086-01, ROCHE-BO17920A |
| Study First Received: | June 2, 2005 |
| Results First Received: | June 1, 2012 |
| Last Updated: | August 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |