Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-resistant Prostate Cancer (READY)
This study is ongoing, but not recruiting participants.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00744497
First received: August 29, 2008
Last updated: December 5, 2014
Last verified: December 2014
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Results First Received: November 15, 2013
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment |
| Condition: |
Prostatic Neoplasms |
| Interventions: |
Drug: Placebo Drug: Dasatinib Drug: Docetaxel Drug: Prednisone |
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 |
|---|
| A total of 1930 participants were enrolled, and 1522 were randomized to a treatment group; 1518 received at least 1 dose of dasatinib (761) or placebo (757). |
Reporting Groups
| Description | |
|---|---|
| Placebo | Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily |
| Dasatinib | Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily |
Participant Flow: Overall Study
| Placebo | Dasatinib | |
|---|---|---|
| STARTED | 760 [1] | 762 [1] |
| Received Treatment | 757 | 761 |
| COMPLETED | 43 [2] | 39 [2] |
| NOT COMPLETED | 717 | 723 |
| Withdrawal by Subject | 21 | 17 |
| Death | 11 | 7 |
| Lost to Follow-up | 4 | 2 |
| Poor compliance/noncompliance | 9 | 4 |
| No longer meets study criteria | 7 | 3 |
| Disease progression | 307 | 208 |
| Study drug toxicity | 68 | 140 |
| Adverse event unrelated to study drug | 77 | 122 |
| Patient requested to stop study drug | 64 | 72 |
| Maximum clinical benefit | 141 | 138 |
| Other | 8 | 10 |
| [1] | Randomized |
|---|---|
| [2] | Remained on study drug |
Baseline Characteristics
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| All participants who were randomized to receive any treatment |
Reporting Groups
| Description | |
|---|---|
| Placebo | Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily |
| Dasatinib | Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily |
| Total | Total of all reporting groups |
Baseline Measures
| Placebo | Dasatinib | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
760 | 762 | 1522 |
|
Age, Customized
[units: participants] |
|||
| Younger than 65 years | 263 | 251 | 514 |
| 65 to younger than 75 years | 323 | 333 | 656 |
| 75 years or older | 174 | 178 | 352 |
|
Gender
[units: participants] |
|||
| Female | 0 | 0 | 0 |
| Male | 760 | 762 | 1522 |
|
Race/Ethnicity, Customized
[units: Participants] |
|||
| Asian | 56 | 55 | 111 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| Black or African American | 34 | 23 | 57 |
| White | 645 | 656 | 1301 |
| Other | 24 | 27 | 51 |
|
Type of metastatic disease
[units: Participants] |
|||
| Bone disease only | 286 | 307 | 593 |
| Visceral/nodal disease only | 73 | 80 | 153 |
| Both bone and visceral/nodal disease | 399 | 373 | 772 |
| No evidence of metastatic disease | 2 | 2 | 4 |
Outcome Measures
Show All Outcome Measures
| 1. Primary: | Overall Survival: Time From Randomization to Date of Death [ Time Frame: From randomization to death or date of last contact (maximum reached: 45 months) ] |
| 2. Secondary: | Percentage of Participants With an Objective Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: At baseline and every 12 weeks thereafter to end of treatment, at end of treatment, and at follow-up (within 42 days of end of dosing) ] |
| 3. Secondary: | Time to First Skeletal-related Event (SRE) [ Time Frame: From day of randomization to date of first SRE or to last SRE assessment, if subsequent cancer therapy begun or no SRE (maximum reached: 42 months) ] |
| 4. Secondary: | Percentage of Participants With A Reduction in Urinary N-telopeptide (uNTx) Level From Baseline [ Time Frame: At baseline, prior to each docetaxel infusion (every 3 weeks) to end of treatment, at end of treatment, and at follow-up (within 14 days of end of dosing) ] |
| 5. Secondary: | Progression-free Survival (PFS) [ Time Frame: From day of randomization to disease progression or death (or to last clinical assessment, if subsequent cancer therapy started or no progression or death) (maximum reached: approximately 43 months) ] |
| 6. Secondary: | Time to Prostate Specific Antigen (PSA) Progression [ Time Frame: From randomization to date of first PSA measurement leading to confirmed PSA progression (or to last bone scan assessment, if no progression or if cancer therapy started) (maximum reached: 30 months) ] |
| 7. Secondary: | Percentage of Participants With a Reduction in Pain Intensity From Baseline [ Time Frame: At baseline, prior to each docetaxel infusion (every 3 weeks), at end of treatment, and at follow-up (within 14 days of end of dosing) ] |
| 8. Other Pre-specified: | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation [ Time Frame: Continuously throughout study to >=30 days after last dose of study drug until resolution of drug-related toxicity, or when toxicity was deemed irreversible, whichever shorter. ] |
| 9. Other Pre-specified: | Number of Participants With Adverse Events (AEs) of Special Interest [ Time Frame: Continuously throughout study to >=30 days after last dose of study drug until resolution of drug-related toxicity, or when toxicity was deemed irreversible, whichever was shorter ] |
Hide Outcome Measure 9
| Measure Type | Other Pre-specified |
|---|---|
| Measure Title | Number of Participants With Adverse Events (AEs) of Special Interest |
| Measure Description | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. AEs of Special Interest=recognized events in other agents within this drug class or events for which safety data from nonclinical and clinical studies with dasatinib indicate that careful evaluation is warranted. AEs of Special Interest are identified by the medical and safety representatives of the sponsor based on MedDRA preferred terms or laboratory data. ANC=absolute neutrophil count. |
| Time Frame | Continuously throughout study to >=30 days after last dose of study drug until resolution of drug-related toxicity, or when toxicity was deemed irreversible, whichever was shorter |
| Safety Issue | Yes |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| All participants who received treatment |
Reporting Groups
| Description | |
|---|---|
| Placebo | Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily |
| Dasatinib | Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily |
Measured Values
| Placebo | Dasatinib | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
757 | 761 |
|
Number of Participants With Adverse Events (AEs) of Special Interest
[units: Participants] |
||
| Myelosuppression: Hemoglobin (n=746, 739) | 712 | 720 |
| Myelosuppression: White blood cells (n=746, 738) | 128 | 149 |
| Myelosuppression: ANC (n=745, 737) | 84 | 161 |
| Myelosuppression: Platelets (n=746, 738) | 108 | 100 |
| Hypocalcemia (n=739, 719) | 308 | 377 |
| Hypophosphotemia (n=733, 720) | 189 | 257 |
| Hypmagnesemia (n=734, 721) | 108 | 98 |
| Diarrhea | 314 | 426 |
| Nausea/vomiting | 268 | 323 |
| Fatigue | 330 | 338 |
| Myalgias/arthralgias | 170 | 142 |
| Rash | 115 | 147 |
| Gastrointestinal tract bleeding | 39 | 72 |
| Central nervous system bleeding | 1 | 4 |
| Other hemorrhage | 134 | 120 |
| Pulmonary arterial hypertension | 0 | 0 |
| Fluid retention: Superficial edema | 237 | 184 |
| Fluid retention: Pleural effusion | 30 | 118 |
| Fluid retention: Other | 85 | 98 |
No statistical analysis provided for Number of Participants With Adverse Events (AEs) of Special Interest
| 10. Other Pre-specified: | Number of Participants With Abnormalities in Results of Clinical Laboratory Tests in Hematology [ Time Frame: At baseline, within 3 days prior to each infusion of docetaxel (each cycle) and at end of treatment. If docetaxel is discontinued, every other cycle. ] |
| 11. Other Pre-specified: | Number of Participants With Abnormalities in Results of Clinical Laboratory Tests Assessing Liver Function, Renal Function, and Electrolytes [ Time Frame: At baseline, within 3 days prior to each infusion of docetaxel (each cycle), to end of treatment. If docetaxel is discontinued, every other cycle. ] |
| 12. Other Pre-specified: | Number of Participants With Abnormal Results in Urinalysis [ Time Frame: At baseline, within 3 days prior to each infusion of docetaxel (each cycle), to end of treatment. If docetaxel is discontinued, every other cycle. ] |
| 13. Other Pre-specified: | Number of Participants by Maximal On-study Fridericia-corrected QTc Interval by Electrocardiogram [ Time Frame: At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing ] |
| 14. Other Pre-specified: | Number of Participants With Changes From Baseline in Fridericia-corrected QTc Interval by Electrocardiogram [ Time Frame: At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing ] |
| 15. Other Pre-specified: | Number of Participants With and Without Pericardial Effusion at Baseline and On-study and With Left Ventricular Ejection Fraction (LVEF) <40% and >=40%On-study by Echocardiogram [ Time Frame: At baseline, approximately 12 weeks after start of treatment, and thereafter whenever clinically indicated ] |
Serious Adverse Events| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
Reporting Groups
| Description | |
|---|---|
| Dasatinib | Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily |
| Placebo | Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily |
Serious Adverse Events
| Dasatinib | Placebo | |
|---|---|---|
| Total, serious adverse events | ||
| # participants affected / at risk | 376/761 (49.41%) | 317/757 (41.88%) |
| Blood and lymphatic system disorders | ||
| Haemorrhagic anaemia † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Disseminated intravascular coagulation † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Neutropenia † 1 | ||
| # participants affected / at risk | 19/761 (2.50%) | 18/757 (2.38%) |
| Agranulocytosis † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Anaemia † 1 | ||
| # participants affected / at risk | 21/761 (2.76%) | 15/757 (1.98%) |
| Febrile bone marrow aplasia † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Febrile neutropenia † 1 | ||
| # participants affected / at risk | 32/761 (4.20%) | 27/757 (3.57%) |
| Hypochromic anaemia † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Thrombocytopenia † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 2/757 (0.26%) |
| Normochromic normocytic anaemia † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Leukopenia † 1 | ||
| # participants affected / at risk | 9/761 (1.18%) | 7/757 (0.92%) |
| Cardiac disorders | ||
| Acute coronary syndrome † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Myocardial infarction † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 1/757 (0.13%) |
| Supraventricular tachycardia † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 2/757 (0.26%) |
| Angina pectoris † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 1/757 (0.13%) |
| Cardiac failure congestive † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 3/757 (0.40%) |
| Sick sinus syndrome † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Supraventricular tachyarrhythmia † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Atrial flutter † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 2/757 (0.26%) |
| Cardiopulmonary failure † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Coronary artery disease † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Pericardial effusion † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Tachycardia † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Atrial fibrillation † 1 | ||
| # participants affected / at risk | 8/761 (1.05%) | 8/757 (1.06%) |
| Cardiac failure † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 3/757 (0.40%) |
| Cardio-respiratory arrest † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Myocardial ischaemia † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 2/757 (0.26%) |
| Atrioventricular block second degree † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Cardiac disorder † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Acute myocardial infarction † 1 | ||
| # participants affected / at risk | 3/761 (0.39%) | 0/757 (0.00%) |
| Arrhythmia † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 0/757 (0.00%) |
| Cardiac arrest † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 1/757 (0.13%) |
| Left ventricular dysfunction † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Congenital, familial and genetic disorders | ||
| Hydrocele † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Eye disorders | ||
| Maculopathy † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Amaurosis fugax † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Gastrointestinal disorders | ||
| Constipation † 1 | ||
| # participants affected / at risk | 5/761 (0.66%) | 10/757 (1.32%) |
| Gastric haemorrhage † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Gastritis erosive † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Inguinal hernia † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Stomatitis † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 1/757 (0.13%) |
| Dyspepsia † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Enteritis † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Haematemesis † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 2/757 (0.26%) |
| Nausea † 1 | ||
| # participants affected / at risk | 14/761 (1.84%) | 7/757 (0.92%) |
| Upper gastrointestinal haemorrhage † 1 | ||
| # participants affected / at risk | 3/761 (0.39%) | 0/757 (0.00%) |
| Ileus † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Abdominal pain upper † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 3/757 (0.40%) |
| Colitis † 1 | ||
| # participants affected / at risk | 4/761 (0.53%) | 0/757 (0.00%) |
| Colonic obstruction † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Gastric ulcer † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 3/757 (0.40%) |
| Gastrointestinal haemorrhage † 1 | ||
| # participants affected / at risk | 8/761 (1.05%) | 7/757 (0.92%) |
| Melaena † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 1/757 (0.13%) |
| Mouth ulceration † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Peptic ulcer † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Abdominal pain † 1 | ||
| # participants affected / at risk | 6/761 (0.79%) | 3/757 (0.40%) |
| Diverticular perforation † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Duodenal ulcer haemorrhage † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Duodenal ulcer perforation † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Gastric ulcer perforation † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Gastrointestinal ulcer † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Haematochezia † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Intestinal perforation † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Proctitis † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Rectal haemorrhage † 1 | ||
| # participants affected / at risk | 8/761 (1.05%) | 5/757 (0.66%) |
| Diarrhoea † 1 | ||
| # participants affected / at risk | 44/761 (5.78%) | 10/757 (1.32%) |
| Dysphagia † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Enterovesical fistula † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Intestinal obstruction † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 2/757 (0.26%) |
| Oesophagitis † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Reflux gastritis † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Subileus † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Anal fistula † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 0/757 (0.00%) |
| Gastrooesophageal reflux disease † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Intra-abdominal haemorrhage † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Periodontal disease † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Volvulus † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Anal fissure † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Lower gastrointestinal haemorrhage † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 0/757 (0.00%) |
| Megacolon † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Proctalgia † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Toothache † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Vomiting † 1 | ||
| # participants affected / at risk | 14/761 (1.84%) | 10/757 (1.32%) |
| General disorders | ||
| Chest pain † 1 | ||
| # participants affected / at risk | 9/761 (1.18%) | 8/757 (1.06%) |
| Pyrexia † 1 | ||
| # participants affected / at risk | 29/761 (3.81%) | 14/757 (1.85%) |
| Face oedema † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Mucosal inflammation † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Oedema † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Spinal pain † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Death † 1 | ||
| # participants affected / at risk | 3/761 (0.39%) | 3/757 (0.40%) |
| Multi-organ failure † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 1/757 (0.13%) |
| Device occlusion † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 2/757 (0.26%) |
| Generalised oedema † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Disease progression † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Malaise † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Performance status decreased † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Asthenia † 1 | ||
| # participants affected / at risk | 13/761 (1.71%) | 7/757 (0.92%) |
| Chills † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Influenza like illness † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Localised oedema † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Sudden death † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 3/757 (0.40%) |
| Fatigue † 1 | ||
| # participants affected / at risk | 15/761 (1.97%) | 9/757 (1.19%) |
| General physical health deterioration † 1 | ||
| # participants affected / at risk | 3/761 (0.39%) | 1/757 (0.13%) |
| Hyperthermia † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Oedema peripheral † 1 | ||
| # participants affected / at risk | 6/761 (0.79%) | 4/757 (0.53%) |
| Pain † 1 | ||
| # participants affected / at risk | 7/761 (0.92%) | 9/757 (1.19%) |
| Hepatobiliary disorders | ||
| Cholecystitis acute † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Hepatic pain † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Hepatotoxicity † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Cholelithiasis † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 2/757 (0.26%) |
| Cholecystitis † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Immune system disorders | ||
| Hypersensitivity † 1 | ||
| # participants affected / at risk | 3/761 (0.39%) | 1/757 (0.13%) |
| Anaphylactic reaction † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Drug hypersensitivity † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 0/757 (0.00%) |
| Infections and infestations | ||
| Erysipelas † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Infectious peritonitis † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Neutropenic sepsis † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 0/757 (0.00%) |
| Respiratory tract infection † 1 | ||
| # participants affected / at risk | 4/761 (0.53%) | 1/757 (0.13%) |
| Staphylococcal sepsis † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 0/757 (0.00%) |
| Upper respiratory tract infection † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Bronchitis † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 3/757 (0.40%) |
| Endocarditis † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Influenza † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Lower respiratory tract infection † 1 | ||
| # participants affected / at risk | 5/761 (0.66%) | 0/757 (0.00%) |
| Pyelonephritis acute † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Urosepsis † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 4/757 (0.53%) |
| Abscess intestinal † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Bacteraemia † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Candidiasis † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Cellulitis † 1 | ||
| # participants affected / at risk | 9/761 (1.18%) | 3/757 (0.40%) |
| Cellulitis of male external genital organ † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Diverticulitis † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 3/757 (0.40%) |
| Lobar pneumonia † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Peritonitis † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Tooth infection † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Cystitis † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Fungal oesophagitis † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Herpes zoster † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 2/757 (0.26%) |
| Neutropenic infection † 1 | ||
| # participants affected / at risk | 3/761 (0.39%) | 3/757 (0.40%) |
| Oesophageal infection † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Oral candidiasis † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Perirectal abscess † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 2/757 (0.26%) |
| Pneumonia † 1 | ||
| # participants affected / at risk | 32/761 (4.20%) | 22/757 (2.91%) |
| Scrotal abscess † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Anal abscess † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 2/757 (0.26%) |
| Bronchopneumonia † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Clostridial infection † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Gangrene † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Gastrointestinal infection † 1 | ||
| # participants affected / at risk | 4/761 (0.53%) | 1/757 (0.13%) |
| Infective exacerbation of chronic obstructive airways disease † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Pneumonia streptococcal † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Septic shock † 1 | ||
| # participants affected / at risk | 9/761 (1.18%) | 3/757 (0.40%) |
| Balanoposthitis infective † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Clostridium difficile colitis † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Device related infection † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Device related sepsis † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Gastroenteritis † 1 | ||
| # participants affected / at risk | 3/761 (0.39%) | 3/757 (0.40%) |
| Sepsis † 1 | ||
| # participants affected / at risk | 6/761 (0.79%) | 6/757 (0.79%) |
| Urinary tract infection † 1 | ||
| # participants affected / at risk | 10/761 (1.31%) | 7/757 (0.92%) |
| Appendicitis † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 3/757 (0.40%) |
| Empyema † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Infection † 1 | ||
| # participants affected / at risk | 8/761 (1.05%) | 4/757 (0.53%) |
| Lung infection † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 0/757 (0.00%) |
| Injury, poisoning and procedural complications | ||
| Clavicle fracture † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Femur fracture † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 2/757 (0.26%) |
| Joint injury † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Procedural complication † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Spinal fracture † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 3/757 (0.40%) |
| Fracture † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Gastroenteritis radiation † 1 | ||
| # participants affected / at risk | 4/761 (0.53%) | 1/757 (0.13%) |
| Overdose † 1 | ||
| # participants affected / at risk | 11/761 (1.45%) | 6/757 (0.79%) |
| Contusion † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Infusion related reaction † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Multiple fractures † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Gastrointestinal anastomotic leak † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Lumbar vertebral fracture † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Upper limb fracture † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Fall † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 3/757 (0.40%) |
| Femoral neck fracture † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Hip fracture † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 1/757 (0.13%) |
| Lower limb fracture † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Spinal compression fracture † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Tracheal obstruction † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Accidental overdose † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Anastomotic leak † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Rib fracture † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Venous injury † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Ulna fracture † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Thoracic vertebral fracture † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Investigations | ||
| Haemoglobin † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Urine output decreased † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Aspartate aminotransferase increased † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Blood creatinine increased † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 1/757 (0.13%) |
| Clostridium test positive † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| General physical condition abnormal † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Neutrophil count † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Bone marrow myelogram abnormal † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Alanine aminotransferase increased † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Eastern Cooperative Oncology Group performance status worsened † 1 | ||
| # participants affected / at risk | 3/761 (0.39%) | 0/757 (0.00%) |
| Platelet count decreased † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Weight decreased † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Haemoglobin decreased † 1 | ||
| # participants affected / at risk | 9/761 (1.18%) | 3/757 (0.40%) |
| Neutrophil count decreased † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 2/757 (0.26%) |
| Transaminases increased † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Metabolism and nutrition disorders | ||
| Fluid overload † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Metabolic acidosis † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 0/757 (0.00%) |
| Decreased appetite † 1 | ||
| # participants affected / at risk | 3/761 (0.39%) | 4/757 (0.53%) |
| Dehydration † 1 | ||
| # participants affected / at risk | 21/761 (2.76%) | 11/757 (1.45%) |
| Hypokalaemia † 1 | ||
| # participants affected / at risk | 3/761 (0.39%) | 2/757 (0.26%) |
| Hypomagnesaemia † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Hyponatraemia † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 3/757 (0.40%) |
| Hypophagia † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Hypocalcaemia † 1 | ||
| # participants affected / at risk | 4/761 (0.53%) | 6/757 (0.79%) |
| Hypoglycaemia † 1 | ||
| # participants affected / at risk | 3/761 (0.39%) | 4/757 (0.53%) |
| Hypophosphataemia † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Hypercalcaemia † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Hyperglycaemia † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 3/757 (0.40%) |
| Malnutrition † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Hyperkalaemia † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Tumour lysis syndrome † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Musculoskeletal and connective tissue disorders | ||
| Back pain † 1 | ||
| # participants affected / at risk | 7/761 (0.92%) | 12/757 (1.59%) |
| Musculoskeletal pain † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 3/757 (0.40%) |
| Pathological fracture † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 1/757 (0.13%) |
| Muscle spasms † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Systemic lupus erythematosus † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Groin pain † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Arthralgia † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 2/757 (0.26%) |
| Fistula † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Hypercreatinaemia † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Muscular weakness † 1 | ||
| # participants affected / at risk | 3/761 (0.39%) | 4/757 (0.53%) |
| Osteonecrosis of jaw † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Bone pain † 1 | ||
| # participants affected / at risk | 4/761 (0.53%) | 7/757 (0.92%) |
| Flank pain † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Neck pain † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Osteoarthritis † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Osteonecrosis † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Pain in extremity † 1 | ||
| # participants affected / at risk | 3/761 (0.39%) | 3/757 (0.40%) |
| Musculoskeletal chest pain † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Metastases to meninges † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Metastasis † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 2/757 (0.26%) |
| Prostate cancer † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 3/757 (0.40%) |
| Cancer pain † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Colorectal cancer recurrent † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Metastatic squamous cell carcinoma † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 0/757 (0.00%) |
| Neoplasm progression † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Adenosquamous cell lung cancer † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Colorectal cancer † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Lip and/or oral cavity cancer † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Basal cell carcinoma † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Meningioma † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Metastatic neoplasm † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Astrocytoma malignant † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Prostate cancer metastatic † 1 | ||
| # participants affected / at risk | 9/761 (1.18%) | 10/757 (1.32%) |
| Rectal cancer † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 2/757 (0.26%) |
| Squamous cell carcinoma of skin † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Neoplasm malignant † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Renal neoplasm † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Non-small cell lung cancer † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Nervous system disorders | ||
| Cerebral ischaemia † 1 | ||
| # participants affected / at risk | 3/761 (0.39%) | 0/757 (0.00%) |
| IIIrd nerve disorder † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Syncope † 1 | ||
| # participants affected / at risk | 4/761 (0.53%) | 5/757 (0.66%) |
| Aphasia † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Ataxia † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Headache † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 1/757 (0.13%) |
| Cerebrovascular accident † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 4/757 (0.53%) |
| Encephalitis † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Ischaemic stroke † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Carotid artery stenosis † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Monoplegia † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Motor dysfunction † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Paraparesis † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Cerebral haemorrhage † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Convulsion † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 0/757 (0.00%) |
| Dizziness † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 2/757 (0.26%) |
| Peripheral motor neuropathy † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 4/757 (0.53%) |
| Depressed level of consciousness † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Haemorrhage intracranial † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Somnolence † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 1/757 (0.13%) |
| Spinal cord compression † 1 | ||
| # participants affected / at risk | 4/761 (0.53%) | 6/757 (0.79%) |
| Transient ischaemic attack † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Central nervous system haemorrhage † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Cerebral haematoma † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Neuralgia † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 2/757 (0.26%) |
| Coma † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Dysarthria † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Intracranial pressure increased † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Nerve root compression † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Peripheral sensory neuropathy † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Psychiatric disorders | ||
| Anxiety † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Depression suicidal † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Confusional state † 1 | ||
| # participants affected / at risk | 6/761 (0.79%) | 2/757 (0.26%) |
| Disorientation † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Mental status changes † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Agitation † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Psychotic disorder † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Renal and urinary disorders | ||
| Renal disorder † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Haematuria † 1 | ||
| # participants affected / at risk | 10/761 (1.31%) | 18/757 (2.38%) |
| Urethral stenosis † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Urinary incontinence † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Bladder outlet obstruction † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Haemoglobinuria † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Haemorrhage urinary tract † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 0/757 (0.00%) |
| Hydronephrosis † 1 | ||
| # participants affected / at risk | 6/761 (0.79%) | 3/757 (0.40%) |
| Renal failure † 1 | ||
| # participants affected / at risk | 5/761 (0.66%) | 5/757 (0.66%) |
| Urinary bladder polyp † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Bladder obstruction † 1 | ||
| # participants affected / at risk | 3/761 (0.39%) | 3/757 (0.40%) |
| Obstructive uropathy † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Renal impairment † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 3/757 (0.40%) |
| Urogenital haemorrhage † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 0/757 (0.00%) |
| Bladder neck obstruction † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Nephrotic syndrome † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 0/757 (0.00%) |
| Renal colic † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Renal failure acute † 1 | ||
| # participants affected / at risk | 8/761 (1.05%) | 4/757 (0.53%) |
| Urinary retention † 1 | ||
| # participants affected / at risk | 9/761 (1.18%) | 9/757 (1.19%) |
| Urinary tract obstruction † 1 | ||
| # participants affected / at risk | 3/761 (0.39%) | 2/757 (0.26%) |
| Dysuria † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Ureteric obstruction † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Ureteric stenosis † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Urinary bladder haemorrhage † 1 | ||
| # participants affected / at risk | 3/761 (0.39%) | 1/757 (0.13%) |
| Reproductive system and breast disorders | ||
| Benign prostatic hyperplasia † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Testicular mass † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Penile pain † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Oedema genital † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 1/757 (0.13%) |
| Prostatic obstruction † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Respiratory, thoracic and mediastinal disorders | ||
| Chronic obstructive pulmonary disease † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Dyspnoea † 1 | ||
| # participants affected / at risk | 21/761 (2.76%) | 10/757 (1.32%) |
| Hypoxia † 1 | ||
| # participants affected / at risk | 3/761 (0.39%) | 1/757 (0.13%) |
| Pleural effusion † 1 | ||
| # participants affected / at risk | 18/761 (2.37%) | 1/757 (0.13%) |
| Productive cough † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Acute respiratory distress syndrome † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 0/757 (0.00%) |
| Interstitial lung disease † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 0/757 (0.00%) |
| Lung infiltration † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Pneumothorax † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 0/757 (0.00%) |
| Pulmonary embolism † 1 | ||
| # participants affected / at risk | 5/761 (0.66%) | 17/757 (2.25%) |
| Pulmonary hypertension † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 0/757 (0.00%) |
| Respiratory failure † 1 | ||
| # participants affected / at risk | 7/761 (0.92%) | 2/757 (0.26%) |
| Acute pulmonary oedema † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Alveolitis † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Dyspnoea exertional † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 2/757 (0.26%) |
| Pneumonitis † 1 | ||
| # participants affected / at risk | 7/761 (0.92%) | 7/757 (0.92%) |
| Pulmonary congestion † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Pulmonary oedema † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 0/757 (0.00%) |
| Cough † 1 | ||
| # participants affected / at risk | 3/761 (0.39%) | 1/757 (0.13%) |
| Lung disorder † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Pulmonary venous thrombosis † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Skin and subcutaneous tissue disorders | ||
| Pyoderma gangrenosum † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Drug eruption † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Peau d'orange † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Rash † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Vascular disorders | ||
| Haemorrhage † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 1/757 (0.13%) |
| Peripheral vascular disorder † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Thrombophlebitis superficial † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Circulatory collapse † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Phlebitis † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 2/757 (0.26%) |
| Vasculitis † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Deep vein thrombosis † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 10/757 (1.32%) |
| Embolism † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Hypotension † 1 | ||
| # participants affected / at risk | 3/761 (0.39%) | 8/757 (1.06%) |
| Vena cava thrombosis † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Haematoma † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Hypertension † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Thrombosis † 1 | ||
| # participants affected / at risk | 2/761 (0.26%) | 0/757 (0.00%) |
| Aortic dissection † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Infarction † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Jugular vein thrombosis † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Shock haemorrhagic † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| Venous thrombosis † 1 | ||
| # participants affected / at risk | 1/761 (0.13%) | 0/757 (0.00%) |
| Venous thrombosis limb † 1 | ||
| # participants affected / at risk | 0/761 (0.00%) | 1/757 (0.13%) |
| † | Events were collected by systematic assessment |
|---|---|
| 1 | Term from vocabulary, MedDRA 15.0 |
Other Adverse Events
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 |
|---|
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