Trial Outcomes & Findings for Zoledronic Acid in Treating Patients With Metastatic Breast Cancer, Metastatic Prostate Cancer, or Multiple Myeloma With Bone Involvement (NCT NCT00869206)
NCT ID: NCT00869206
Last Updated: 2018-11-07
Results Overview
To determine whether every-12-week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with metastatic breast cancer, metastatic prostate cancer, or multiple myeloma involving bone, as measured by the proportion of patients who would have experienced at least one skeletal related event within 24 months after randomization.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1822 participants
Primary outcome timeframe
2 years
Results posted on
2018-11-07
Participant Flow
Participant milestones
| Measure |
Arm I (Zoledronic Acid Every 4 Weeks)
Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Arm II (Zoledronic Acid Every 12 Weeks)
Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
911
|
911
|
|
Overall Study
COMPLETED
|
882
|
884
|
|
Overall Study
NOT COMPLETED
|
29
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zoledronic Acid in Treating Patients With Metastatic Breast Cancer, Metastatic Prostate Cancer, or Multiple Myeloma With Bone Involvement
Baseline characteristics by cohort
| Measure |
Arm I (Zoledronic Acid Every 4 Weeks)
n=911 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Arm II (Zoledronic Acid Every 12 Weeks)
n=911 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Total
n=1822 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
65.3 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
65.3 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
414 Participants
n=5 Participants
|
428 Participants
n=7 Participants
|
842 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
497 Participants
n=5 Participants
|
483 Participants
n=7 Participants
|
980 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
911 participants
n=5 Participants
|
911 participants
n=7 Participants
|
1822 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: All patients that were eligible and completed treatment were analyzed.
To determine whether every-12-week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with metastatic breast cancer, metastatic prostate cancer, or multiple myeloma involving bone, as measured by the proportion of patients who would have experienced at least one skeletal related event within 24 months after randomization.
Outcome measures
| Measure |
Arm I (Zoledronic Acid Every 4 Weeks)
n=911 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Arm II (Zoledronic Acid Every 12 Weeks)
n=911 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Percentage of Participants With at Least One Skeletal-related Event (SRE) Within 2 Years After Randomization
|
67.6 percentage of participants
|
67.9 percentage of participants
|
SECONDARY outcome
Timeframe: from baseline up to 2 yearsPopulation: 1766 patients completed treatment and were analyzed.
To compare pain scores (Brief Pain Inventory) of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The change scores were evaluated in a general linear model with repeated measures for treatment effect and the time trend with patient-specific characteristics being adjusted for the mean interference score. Specifically the difference in score change per 4 weeks for Arm I using Arm II as the reference is reported. The score of the BPI questionnaire ranges from 0 being no pain to 10 being the most pain. The average score is reported for each arm below.
Outcome measures
| Measure |
Arm I (Zoledronic Acid Every 4 Weeks)
n=882 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Arm II (Zoledronic Acid Every 12 Weeks)
n=884 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Average Pain Intensity Score as Assessed by the Brief Pain Inventory (BPI) Questionnaire
|
2.06 score on a scale
Standard Error 0.14
|
2.09 score on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: from baseline up to 2 yearsPopulation: 1766 patients completed treatment and were analyzed.
To compare functional status (ECOG performance status) of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The change scores were evaluated in a general linear model with repeated measures for treatment effect and the time trend with patient-specific characteristics being adjusted. Specifically the difference in score change per 4 weeks for Arm I using Arm II as the reference is reported. ECOG performance status is a measurement of a patients disability ranging from 0, fully active and able to carry out all pre disease performance without restriction, to 5, dead. The average performance status is reported below by arm.
Outcome measures
| Measure |
Arm I (Zoledronic Acid Every 4 Weeks)
n=882 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Arm II (Zoledronic Acid Every 12 Weeks)
n=884 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Average ECOG Performance Status
|
0.82 score on a scale
Standard Error 0.042
|
0.84 score on a scale
Standard Error 0.042
|
SECONDARY outcome
Timeframe: from baseline up to 2 yearsPopulation: 1766 patients completed treatment and were analyzed.
To compare the incidence of osteonecrosis of the jaw in patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The percentage of participants with osteonecrosis is reported here.
Outcome measures
| Measure |
Arm I (Zoledronic Acid Every 4 Weeks)
n=882 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Arm II (Zoledronic Acid Every 12 Weeks)
n=884 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Incidence of Osteonecrosis of the Jaw
|
2.0 percentage of participants
|
1.0 percentage of participants
|
SECONDARY outcome
Timeframe: from baseline up to 2 yearsPopulation: 1689 patients completed treatment and were analyzed.
To compare the incidence of renal dysfunction of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The percentage of patients with renal dysfunction, defined as grade 3 or grade 4 increased creatinine (Common Terminology Criteria for Adverse Events version 3.0), will be reported here.
Outcome measures
| Measure |
Arm I (Zoledronic Acid Every 4 Weeks)
n=852 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Arm II (Zoledronic Acid Every 12 Weeks)
n=837 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Incidence of Renal Dysfunction
|
1.2 percentage of participants
|
.5 percentage of participants
|
SECONDARY outcome
Timeframe: from baseline up to 2 yearsPopulation: 1766 patients were treated and analyzed.
To compare the skeletal morbidity rate, defined as the number of skeletal-related events per year, of patients receiving every 12 week dosing to those receiving every 4 week dosing.
Outcome measures
| Measure |
Arm I (Zoledronic Acid Every 4 Weeks)
n=882 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Arm II (Zoledronic Acid Every 12 Weeks)
n=884 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Skeletal Morbidity Rate
|
.4 SRE's per year
Standard Deviation 1.0
|
.4 SRE's per year
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: from baseline up to 2 yearsPopulation: 266 breast cancer patients who were treated and included in this portion of the substudy.
To compare the suppression of serum markers of bone resorption of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The number of patients with high \& low CTX values by arm will be reported here.
Outcome measures
| Measure |
Arm I (Zoledronic Acid Every 4 Weeks)
n=137 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Arm II (Zoledronic Acid Every 12 Weeks)
n=129 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Breast Cancer)
Low CTX (<0.415ng/ml)
|
83 Participants
|
75 Participants
|
|
Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Breast Cancer)
High CTX (>0.415ng/ml)
|
54 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: from baseline up to 24 monthsPopulation: 820 patients completed treatment and were analyzed.
To determine whether every 12 week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with breast cancer, as measured by the proportion who experience at least one skeletal related event within 24 months after randomization.
Outcome measures
| Measure |
Arm I (Zoledronic Acid Every 4 Weeks)
n=410 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Arm II (Zoledronic Acid Every 12 Weeks)
n=410 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Breast Cancer
|
113 Participants
|
119 Participants
|
SECONDARY outcome
Timeframe: from baseline up to 24 monthsPopulation: 660 patients completed treatment and were analyzed.
To determine whether every 12 week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with prostate cancer, as measured by the proportion who experience at least one skeletal related event within 24 months after randomization.
Outcome measures
| Measure |
Arm I (Zoledronic Acid Every 4 Weeks)
n=330 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Arm II (Zoledronic Acid Every 12 Weeks)
n=330 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Prostate Cancer
|
107 Participants
|
101 Participants
|
SECONDARY outcome
Timeframe: from baseline up to 24 monthsPopulation: 265 patient completed treatment and were analyzed.
To determine whether every 12 week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with multiple myeloma, as measured by the proportion who experience at least one skeletal related event within 24 months after randomization.
Outcome measures
| Measure |
Arm I (Zoledronic Acid Every 4 Weeks)
n=130 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Arm II (Zoledronic Acid Every 12 Weeks)
n=135 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Multiple Myeloma
|
35 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: from baseline up to 24 monthsPopulation: 207 prostate cancer patients who were treated and included in this portion of the substudy.
To compare the suppression of serum markers of bone resorption of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The number of patients with high \& low CTX values by arm will be reported here.
Outcome measures
| Measure |
Arm I (Zoledronic Acid Every 4 Weeks)
n=104 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Arm II (Zoledronic Acid Every 12 Weeks)
n=103 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Prostate Cancer)
Low CTX (<0.415ng/ml)
|
34 Participants
|
49 Participants
|
|
Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Prostate Cancer)
High CTX (>.0.415ng/ml)
|
70 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: from baseline up to 24 monthsPopulation: 74 multiple myeloma patients were treated and included in this portion of the substudy.
To compare the suppression of serum markers of bone resorption of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The number of patients with high \& low CTX values by arm will be reported here.
Outcome measures
| Measure |
Arm I (Zoledronic Acid Every 4 Weeks)
n=38 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Arm II (Zoledronic Acid Every 12 Weeks)
n=36 Participants
Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Multiple Myeloma)
Low CTX (<0.415ng/ml)
|
15 Participants
|
19 Participants
|
|
Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Multiple Myeloma)
High CTX (>.0.415ng/ml)
|
23 Participants
|
17 Participants
|
Adverse Events
Arm I (Zoledronic Acid Every 4 Weeks)
Serious events: 96 serious events
Other events: 779 other events
Deaths: 41 deaths
Arm II (Zoledronic Acid Every 12 Weeks)
Serious events: 103 serious events
Other events: 750 other events
Deaths: 42 deaths
Serious adverse events
| Measure |
Arm I (Zoledronic Acid Every 4 Weeks)
n=879 participants at risk
Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Arm II (Zoledronic Acid Every 12 Weeks)
n=868 participants at risk
Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Bone marrow hypocellular
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.11%
1/879 • Number of events 1
|
0.46%
4/868 • Number of events 4
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
0.91%
8/879 • Number of events 8
|
1.2%
10/868 • Number of events 11
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.23%
2/879 • Number of events 2
|
0.00%
0/868
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/879
|
0.12%
1/868 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Cardiac disorders
Cardiac disorder
|
0.34%
3/879 • Number of events 3
|
0.12%
1/868 • Number of events 2
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/879
|
0.12%
1/868 • Number of events 2
|
|
Cardiac disorders
Cardiopulmonary arrest
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Cardiac disorders
Conduction disorder
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Cardiac disorders
Left ventricular failure
|
0.11%
1/879 • Number of events 2
|
0.00%
0/868
|
|
Cardiac disorders
Myocardial ischemia
|
0.34%
3/879 • Number of events 3
|
0.00%
0/868
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.00%
0/879
|
0.12%
1/868 • Number of events 2
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/879
|
0.23%
2/868 • Number of events 3
|
|
Cardiac disorders
Sinus bradycardia
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/879
|
0.35%
3/868 • Number of events 3
|
|
Cardiac disorders
Ventricular tachycardia
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Gastrointestinal disorders
Abdominal distension
|
0.23%
2/879 • Number of events 2
|
0.00%
0/868
|
|
Gastrointestinal disorders
Abdominal pain
|
0.34%
3/879 • Number of events 3
|
0.35%
3/868 • Number of events 3
|
|
Gastrointestinal disorders
Ascites
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Gastrointestinal disorders
Colitis
|
0.23%
2/879 • Number of events 2
|
0.00%
0/868
|
|
Gastrointestinal disorders
Colonic perforation
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Gastrointestinal disorders
Constipation
|
0.91%
8/879 • Number of events 8
|
1.4%
12/868 • Number of events 14
|
|
Gastrointestinal disorders
Diarrhea
|
1.4%
12/879 • Number of events 13
|
1.3%
11/868 • Number of events 11
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Gastrointestinal disorders
Dysphagia
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Gastrointestinal disorders
Nausea
|
1.5%
13/879 • Number of events 13
|
1.8%
16/868 • Number of events 17
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/879
|
0.23%
2/868 • Number of events 2
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Gastrointestinal disorders
Proctitis
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
9/879 • Number of events 9
|
1.0%
9/868 • Number of events 10
|
|
General disorders
Chest pain
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
General disorders
Death NOS
|
1.6%
14/879 • Number of events 14
|
1.6%
14/868 • Number of events 14
|
|
General disorders
Disease progression
|
1.1%
10/879 • Number of events 10
|
1.7%
15/868 • Number of events 15
|
|
General disorders
Edema limbs
|
0.11%
1/879 • Number of events 1
|
0.35%
3/868 • Number of events 4
|
|
General disorders
Fatigue
|
0.68%
6/879 • Number of events 6
|
1.0%
9/868 • Number of events 10
|
|
General disorders
Fever
|
0.34%
3/879 • Number of events 3
|
1.0%
9/868 • Number of events 9
|
|
General disorders
Flu-like symptoms
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
General disorders
General symptom
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 2
|
|
General disorders
Multi-organ failure
|
0.23%
2/879 • Number of events 2
|
0.12%
1/868 • Number of events 1
|
|
General disorders
Pain
|
0.34%
3/879 • Number of events 3
|
0.12%
1/868 • Number of events 1
|
|
Hepatobiliary disorders
Biliary fistula
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Hepatobiliary disorders
Gallbladder necrosis
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Infections and infestations
Bladder infection
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Infections and infestations
Bone infection
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Infections and infestations
Infection
|
0.34%
3/879 • Number of events 3
|
0.23%
2/868 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
0.23%
2/879 • Number of events 2
|
0.46%
4/868 • Number of events 5
|
|
Infections and infestations
Sepsis
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Infections and infestations
Skin infection
|
0.23%
2/879 • Number of events 2
|
0.12%
1/868 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.34%
3/879 • Number of events 3
|
0.23%
2/868 • Number of events 2
|
|
Injury, poisoning and procedural complications
Intraoperative musculoskeletal injury
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Injury, poisoning and procedural complications
Intraoperative neurological injury - Spinal cord
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Investigations
Alanine aminotransferase increased
|
0.46%
4/879 • Number of events 4
|
0.23%
2/868 • Number of events 2
|
|
Investigations
Alkaline phosphatase increased
|
0.34%
3/879 • Number of events 3
|
0.23%
2/868 • Number of events 3
|
|
Investigations
Aspartate aminotransferase increased
|
1.0%
9/879 • Number of events 9
|
0.12%
1/868 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
0.23%
2/879 • Number of events 2
|
0.12%
1/868 • Number of events 1
|
|
Investigations
Cardiac troponin I increased
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Investigations
Cardiac troponin T increased
|
0.23%
2/879 • Number of events 2
|
0.00%
0/868
|
|
Investigations
Creatine phosphokinase increased
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Investigations
Creatinine increased
|
0.23%
2/879 • Number of events 2
|
0.12%
1/868 • Number of events 1
|
|
Investigations
Electrocardiogram QTc interval prolonged
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Investigations
INR increased
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
0.00%
0/879
|
0.46%
4/868 • Number of events 4
|
|
Investigations
Lymphocyte count decreased
|
0.46%
4/879 • Number of events 4
|
0.69%
6/868 • Number of events 6
|
|
Investigations
Neutrophil count decreased
|
0.23%
2/879 • Number of events 2
|
0.69%
6/868 • Number of events 6
|
|
Investigations
Platelet count decreased
|
0.57%
5/879 • Number of events 5
|
0.46%
4/868 • Number of events 4
|
|
Investigations
Weight loss
|
0.23%
2/879 • Number of events 2
|
0.23%
2/868 • Number of events 2
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/879
|
0.23%
2/868 • Number of events 2
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/879
|
0.23%
2/868 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
0.23%
2/879 • Number of events 2
|
0.12%
1/868 • Number of events 1
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
0.11%
1/879 • Number of events 1
|
0.58%
5/868 • Number of events 5
|
|
Metabolism and nutrition disorders
Dehydration
|
0.46%
4/879 • Number of events 4
|
0.46%
4/868 • Number of events 6
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/879
|
0.12%
1/868 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
0.11%
1/879 • Number of events 1
|
0.58%
5/868 • Number of events 5
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
3.2%
28/879 • Number of events 32
|
3.9%
34/868 • Number of events 39
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
0.00%
0/879
|
0.23%
2/868 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
0.80%
7/879 • Number of events 8
|
1.0%
9/868 • Number of events 10
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.46%
4/879 • Number of events 5
|
1.3%
11/868 • Number of events 11
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
0.57%
5/879 • Number of events 6
|
0.69%
6/868 • Number of events 6
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.23%
2/879 • Number of events 2
|
0.23%
2/868 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
0.11%
1/879 • Number of events 1
|
1.3%
11/868 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.23%
2/879 • Number of events 2
|
0.12%
1/868 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.91%
8/879 • Number of events 8
|
0.46%
4/868 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.57%
5/879 • Number of events 5
|
0.35%
3/868 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.11%
1/879 • Number of events 1
|
0.46%
4/868 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.46%
4/879 • Number of events 4
|
0.46%
4/868 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.23%
2/879 • Number of events 2
|
0.12%
1/868 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplasia
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/879
|
0.23%
2/868 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.34%
3/879 • Number of events 3
|
0.12%
1/868 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.11%
1/879 • Number of events 1
|
0.23%
2/868 • Number of events 2
|
|
Psychiatric disorders
Confusion
|
0.00%
0/879
|
0.46%
4/868 • Number of events 5
|
|
Psychiatric disorders
Depression
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.23%
2/879 • Number of events 2
|
0.00%
0/868
|
|
Renal and urinary disorders
Renal failure
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Renal and urinary disorders
Urogenital disorder
|
2.6%
23/879 • Number of events 30
|
2.1%
18/868 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.00%
0/879
|
0.12%
1/868 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.23%
2/879 • Number of events 2
|
0.00%
0/868
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.11%
1/879 • Number of events 1
|
0.35%
3/868 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.68%
6/879 • Number of events 6
|
0.81%
7/868 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.68%
6/879 • Number of events 6
|
0.58%
5/868 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.11%
1/879 • Number of events 1
|
0.23%
2/868 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.11%
1/879 • Number of events 1
|
0.23%
2/868 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.11%
1/879 • Number of events 1
|
0.46%
4/868 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Vascular disorders
Hematoma
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Vascular disorders
Hemorrhage
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.34%
3/879 • Number of events 3
|
1.0%
9/868 • Number of events 9
|
|
Vascular disorders
Thrombosis
|
0.23%
2/879 • Number of events 4
|
1.0%
9/868 • Number of events 9
|
Other adverse events
| Measure |
Arm I (Zoledronic Acid Every 4 Weeks)
n=879 participants at risk
Patients receive zoledronic acid IV over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Arm II (Zoledronic Acid Every 12 Weeks)
n=868 participants at risk
Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
0.23%
2/879 • Number of events 2
|
0.23%
2/868 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.1%
10/879 • Number of events 14
|
0.81%
7/868 • Number of events 8
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
11.1%
98/879 • Number of events 195
|
10.6%
92/868 • Number of events 206
|
|
Blood and lymphatic system disorders
Hemolysis
|
1.8%
16/879 • Number of events 37
|
1.3%
11/868 • Number of events 29
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
0.34%
3/879 • Number of events 5
|
0.12%
1/868 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.46%
4/879 • Number of events 5
|
0.12%
1/868 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
9/879 • Number of events 9
|
0.23%
2/868 • Number of events 2
|
|
Cardiac disorders
Atrial flutter
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Cardiac disorders
Cardiac disorder
|
0.34%
3/879 • Number of events 3
|
0.46%
4/868 • Number of events 4
|
|
Cardiac disorders
Cardiac pain
|
0.23%
2/879 • Number of events 2
|
0.12%
1/868 • Number of events 1
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/879
|
0.23%
2/868 • Number of events 2
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.46%
4/879 • Number of events 4
|
0.35%
3/868 • Number of events 3
|
|
Cardiac disorders
Left ventricular failure
|
0.80%
7/879 • Number of events 8
|
0.23%
2/868 • Number of events 3
|
|
Cardiac disorders
Myocardial ischemia
|
0.80%
7/879 • Number of events 7
|
0.12%
1/868 • Number of events 2
|
|
Cardiac disorders
Palpitations
|
0.00%
0/879
|
0.23%
2/868 • Number of events 2
|
|
Cardiac disorders
Pericardial effusion
|
0.23%
2/879 • Number of events 2
|
0.12%
1/868 • Number of events 1
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.23%
2/879 • Number of events 2
|
0.23%
2/868 • Number of events 2
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Cardiac disorders
Ventricular tachycardia
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain
|
0.23%
2/879 • Number of events 2
|
0.12%
1/868 • Number of events 1
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.34%
3/879 • Number of events 8
|
0.12%
1/868 • Number of events 1
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/879
|
0.12%
1/868 • Number of events 2
|
|
Ear and labyrinth disorders
Tinnitus
|
0.11%
1/879 • Number of events 2
|
0.12%
1/868 • Number of events 5
|
|
Endocrine disorders
Cushingoid
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 2
|
|
Endocrine disorders
Endocrine disorder
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Eye disorders
Cataract
|
0.46%
4/879 • Number of events 5
|
0.35%
3/868 • Number of events 3
|
|
Eye disorders
Diplopia
|
0.11%
1/879 • Number of events 6
|
0.23%
2/868 • Number of events 3
|
|
Eye disorders
Dry eye syndrome
|
0.00%
0/879
|
0.12%
1/868 • Number of events 2
|
|
Eye disorders
Extraocular muscle paresis
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Eye disorders
Eye disorder
|
0.46%
4/879 • Number of events 5
|
0.58%
5/868 • Number of events 23
|
|
Eye disorders
Optic nerve disorder
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Eye disorders
Retinal detachment
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.23%
2/879 • Number of events 2
|
0.23%
2/868 • Number of events 2
|
|
Eye disorders
Vitreous hemorrhage
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Eye disorders
Watering eyes
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
0.57%
5/879 • Number of events 6
|
0.23%
2/868 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
4.6%
40/879 • Number of events 74
|
4.8%
42/868 • Number of events 68
|
|
Gastrointestinal disorders
Anal exam abnormal
|
0.11%
1/879 • Number of events 2
|
0.00%
0/868
|
|
Gastrointestinal disorders
Anal fistula
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Gastrointestinal disorders
Ascites
|
0.80%
7/879 • Number of events 15
|
0.12%
1/868 • Number of events 2
|
|
Gastrointestinal disorders
Colitis
|
0.46%
4/879 • Number of events 4
|
0.35%
3/868 • Number of events 3
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
39.6%
348/879 • Number of events 1527
|
38.4%
333/868 • Number of events 1341
|
|
Gastrointestinal disorders
Dental prosthesis user
|
0.23%
2/879 • Number of events 5
|
0.23%
2/868 • Number of events 10
|
|
Gastrointestinal disorders
Diarrhea
|
31.4%
276/879 • Number of events 693
|
31.7%
275/868 • Number of events 754
|
|
Gastrointestinal disorders
Dry mouth
|
0.57%
5/879 • Number of events 5
|
0.46%
4/868 • Number of events 25
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.46%
4/879 • Number of events 4
|
0.35%
3/868 • Number of events 6
|
|
Gastrointestinal disorders
Dysphagia
|
0.34%
3/879 • Number of events 3
|
0.69%
6/868 • Number of events 11
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
0.46%
4/879 • Number of events 4
|
0.23%
2/868 • Number of events 4
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
0.11%
1/879 • Number of events 2
|
0.00%
0/868
|
|
Gastrointestinal disorders
Esophageal mucositis
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Gastrointestinal disorders
Esophageal pain
|
0.23%
2/879 • Number of events 2
|
0.23%
2/868 • Number of events 2
|
|
Gastrointestinal disorders
Esophagitis
|
0.23%
2/879 • Number of events 2
|
0.12%
1/868 • Number of events 1
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.23%
2/879 • Number of events 6
|
0.12%
1/868 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.34%
3/879 • Number of events 4
|
0.00%
0/868
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.46%
4/879 • Number of events 4
|
0.46%
4/868 • Number of events 4
|
|
Gastrointestinal disorders
Gingival pain
|
0.68%
6/879 • Number of events 9
|
0.69%
6/868 • Number of events 6
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
0.23%
2/879 • Number of events 2
|
0.58%
5/868 • Number of events 6
|
|
Gastrointestinal disorders
Nausea
|
41.8%
367/879 • Number of events 1187
|
41.1%
357/868 • Number of events 1069
|
|
Gastrointestinal disorders
Oesophagoscopy abnormal
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Gastrointestinal disorders
Oral pain
|
0.80%
7/879 • Number of events 8
|
0.69%
6/868 • Number of events 15
|
|
Gastrointestinal disorders
Pancreatitis
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/879
|
0.23%
2/868 • Number of events 2
|
|
Gastrointestinal disorders
Rectal pain
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.11%
1/879 • Number of events 1
|
0.35%
3/868 • Number of events 3
|
|
Gastrointestinal disorders
Stomach pain
|
0.23%
2/879 • Number of events 2
|
0.58%
5/868 • Number of events 7
|
|
Gastrointestinal disorders
Tooth development disorder
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Gastrointestinal disorders
Toothache
|
0.46%
4/879 • Number of events 4
|
0.69%
6/868 • Number of events 12
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
25.5%
224/879 • Number of events 441
|
22.8%
198/868 • Number of events 366
|
|
General disorders
Chest pain
|
1.4%
12/879 • Number of events 14
|
2.2%
19/868 • Number of events 50
|
|
General disorders
Chills
|
0.34%
3/879 • Number of events 4
|
0.00%
0/868
|
|
General disorders
Edema limbs
|
1.8%
16/879 • Number of events 26
|
2.5%
22/868 • Number of events 51
|
|
General disorders
Facial pain
|
0.46%
4/879 • Number of events 11
|
0.00%
0/868
|
|
General disorders
Fatigue
|
10.2%
90/879 • Number of events 216
|
10.0%
87/868 • Number of events 260
|
|
General disorders
Fever
|
19.7%
173/879 • Number of events 291
|
21.8%
189/868 • Number of events 298
|
|
General disorders
Flu-like symptoms
|
0.23%
2/879 • Number of events 12
|
0.46%
4/868 • Number of events 4
|
|
General disorders
Gait abnormal
|
0.46%
4/879 • Number of events 4
|
0.12%
1/868 • Number of events 1
|
|
General disorders
General symptom
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
General disorders
Ill-defined disorder
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
General disorders
Injection site reaction
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
General disorders
Localized edema
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
General disorders
Pain
|
11.0%
97/879 • Number of events 275
|
7.8%
68/868 • Number of events 157
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.11%
1/879 • Number of events 1
|
0.46%
4/868 • Number of events 4
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.23%
2/879 • Number of events 3
|
0.00%
0/868
|
|
Hepatobiliary disorders
Gallbladder pain
|
0.00%
0/879
|
0.23%
2/868 • Number of events 2
|
|
Hepatobiliary disorders
Hepatic pain
|
0.46%
4/879 • Number of events 5
|
0.12%
1/868 • Number of events 6
|
|
Immune system disorders
Hypersensitivity
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Infections and infestations
Abdominal infection
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Infections and infestations
Anal infection
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Infections and infestations
Appendicitis perforated
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Infections and infestations
Bladder infection
|
0.34%
3/879 • Number of events 3
|
0.23%
2/868 • Number of events 2
|
|
Infections and infestations
Bone infection
|
0.68%
6/879 • Number of events 6
|
0.12%
1/868 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.34%
3/879 • Number of events 3
|
0.00%
0/868
|
|
Infections and infestations
Catheter related infection
|
0.80%
7/879 • Number of events 11
|
0.23%
2/868 • Number of events 3
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
0.11%
1/879 • Number of events 2
|
0.12%
1/868 • Number of events 3
|
|
Infections and infestations
Device related infection
|
0.00%
0/879
|
0.35%
3/868 • Number of events 3
|
|
Infections and infestations
Endocarditis infective
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Infections and infestations
Esophageal infection
|
0.00%
0/879
|
0.23%
2/868 • Number of events 2
|
|
Infections and infestations
Eye infection
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Infections and infestations
Gallbladder infection
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Infections and infestations
Gingival infection
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Infections and infestations
Ileal infection
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Infections and infestations
Infection
|
1.4%
12/879 • Number of events 17
|
1.8%
16/868 • Number of events 20
|
|
Infections and infestations
Joint infection
|
0.11%
1/879 • Number of events 2
|
0.00%
0/868
|
|
Infections and infestations
Lip infection
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Infections and infestations
Lymph gland infection
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Infections and infestations
Mucosal infection
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Infections and infestations
Nail infection
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Infections and infestations
Opportunistic infection
|
0.11%
1/879 • Number of events 1
|
0.23%
2/868 • Number of events 2
|
|
Infections and infestations
Peripheral nerve infection
|
0.23%
2/879 • Number of events 2
|
0.23%
2/868 • Number of events 2
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/879
|
0.23%
2/868 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
1.8%
16/879 • Number of events 17
|
2.2%
19/868 • Number of events 20
|
|
Infections and infestations
Prostate infection
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.34%
3/879 • Number of events 3
|
0.35%
3/868 • Number of events 3
|
|
Infections and infestations
Sinusitis
|
0.34%
3/879 • Number of events 3
|
0.12%
1/868 • Number of events 1
|
|
Infections and infestations
Skin infection
|
1.5%
13/879 • Number of events 14
|
0.58%
5/868 • Number of events 5
|
|
Infections and infestations
Small intestine infection
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/879
|
0.23%
2/868 • Number of events 2
|
|
Infections and infestations
Tooth infection
|
0.57%
5/879 • Number of events 6
|
0.23%
2/868 • Number of events 3
|
|
Infections and infestations
Upper aerodigestive tract infection
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Infections and infestations
Ureteritis
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Infections and infestations
Urinary tract infection
|
2.2%
19/879 • Number of events 22
|
1.5%
13/868 • Number of events 14
|
|
Infections and infestations
Uterine infection
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Infections and infestations
Wound infection
|
0.23%
2/879 • Number of events 3
|
0.12%
1/868 • Number of events 2
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/879
|
0.23%
2/868 • Number of events 2
|
|
Injury, poisoning and procedural complications
Bruising
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Injury, poisoning and procedural complications
Fracture
|
0.80%
7/879 • Number of events 8
|
1.6%
14/868 • Number of events 28
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma necrosis
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Injury, poisoning and procedural complications
Intraoperative complications
|
0.23%
2/879 • Number of events 2
|
0.12%
1/868 • Number of events 1
|
|
Injury, poisoning and procedural complications
Intraoperative musculoskeletal injury - Extremity-lower
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Injury, poisoning and procedural complications
Intraoperative neurological injury
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Injury, poisoning and procedural complications
Intraoperative neurological injury - NERVES: Sacral plexus
|
0.00%
0/879
|
0.12%
1/868 • Number of events 2
|
|
Injury, poisoning and procedural complications
Prolonged intubation after pulmonary resection (>24 hrs after surgery)
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
0.00%
0/879
|
0.23%
2/868 • Number of events 3
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/879
|
0.12%
1/868 • Number of events 2
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.23%
2/879 • Number of events 2
|
0.35%
3/868 • Number of events 4
|
|
Investigations
ADH abnormal
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.23%
2/879 • Number of events 2
|
0.23%
2/868 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
2.3%
20/879 • Number of events 27
|
1.6%
14/868 • Number of events 23
|
|
Investigations
Alkaline phosphatase increased
|
5.2%
46/879 • Number of events 99
|
3.9%
34/868 • Number of events 80
|
|
Investigations
Amylase increased
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
4.4%
39/879 • Number of events 58
|
2.6%
23/868 • Number of events 29
|
|
Investigations
Blood bilirubin increased
|
1.7%
15/879 • Number of events 17
|
1.4%
12/868 • Number of events 18
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/879
|
0.23%
2/868 • Number of events 2
|
|
Investigations
Cardiac troponin T increased
|
0.23%
2/879 • Number of events 2
|
0.00%
0/868
|
|
Investigations
Coagulopathy
|
0.00%
0/879
|
0.23%
2/868 • Number of events 2
|
|
Investigations
Creatine phosphokinase increased
|
0.23%
2/879 • Number of events 4
|
0.23%
2/868 • Number of events 2
|
|
Investigations
Creatinine increased
|
1.6%
14/879 • Number of events 23
|
1.2%
10/868 • Number of events 10
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.11%
1/879 • Number of events 2
|
0.00%
0/868
|
|
Investigations
INR increased
|
0.91%
8/879 • Number of events 28
|
0.46%
4/868 • Number of events 18
|
|
Investigations
Laboratory test abnormal
|
0.46%
4/879 • Number of events 6
|
0.00%
0/868
|
|
Investigations
Leukocyte count decreased
|
7.7%
68/879 • Number of events 128
|
8.1%
70/868 • Number of events 160
|
|
Investigations
Lipase increased
|
0.11%
1/879 • Number of events 1
|
0.23%
2/868 • Number of events 3
|
|
Investigations
Lymphocyte count decreased
|
4.7%
41/879 • Number of events 126
|
5.2%
45/868 • Number of events 143
|
|
Investigations
Neutrophil count decreased
|
9.0%
79/879 • Number of events 131
|
8.1%
70/868 • Number of events 118
|
|
Investigations
Platelet count decreased
|
6.0%
53/879 • Number of events 108
|
6.8%
59/868 • Number of events 138
|
|
Investigations
Serum cholesterol increased
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Investigations
Weight gain
|
0.46%
4/879 • Number of events 24
|
0.69%
6/868 • Number of events 32
|
|
Investigations
Weight loss
|
1.3%
11/879 • Number of events 27
|
1.6%
14/868 • Number of events 30
|
|
Metabolism and nutrition disorders
Acidosis
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
3.2%
28/879 • Number of events 48
|
2.8%
24/868 • Number of events 39
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
0.00%
0/879
|
0.35%
3/868 • Number of events 3
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
4.9%
43/879 • Number of events 150
|
6.6%
57/868 • Number of events 181
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
20/879 • Number of events 23
|
2.5%
22/868 • Number of events 22
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/879
|
0.23%
2/868 • Number of events 29
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
2.5%
22/879 • Number of events 30
|
1.4%
12/868 • Number of events 18
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
36.4%
320/879 • Number of events 996
|
33.4%
290/868 • Number of events 839
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
9.9%
87/879 • Number of events 177
|
9.4%
82/868 • Number of events 207
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
0.46%
4/879 • Number of events 5
|
0.58%
5/868 • Number of events 9
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
6.4%
56/879 • Number of events 101
|
7.0%
61/868 • Number of events 93
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
7.3%
64/879 • Number of events 95
|
7.9%
69/868 • Number of events 130
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
3.4%
30/879 • Number of events 41
|
3.0%
26/868 • Number of events 45
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
1.3%
11/879 • Number of events 13
|
1.3%
11/868 • Number of events 12
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
3.5%
31/879 • Number of events 45
|
3.2%
28/868 • Number of events 38
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
0.11%
1/879 • Number of events 1
|
0.23%
2/868 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum triglycerides increased
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.6%
93/879 • Number of events 307
|
9.6%
83/868 • Number of events 311
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.0%
9/879 • Number of events 20
|
0.46%
4/868 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.7%
191/879 • Number of events 792
|
20.4%
177/868 • Number of events 688
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
15.8%
139/879 • Number of events 595
|
15.1%
131/868 • Number of events 452
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
2.7%
24/879 • Number of events 52
|
2.0%
17/868 • Number of events 32
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.8%
25/879 • Number of events 74
|
2.4%
21/868 • Number of events 39
|
|
Musculoskeletal and connective tissue disorders
Fibrosis
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased cervical spine
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased lumbar spine
|
0.00%
0/879
|
0.12%
1/868 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
2.5%
22/879 • Number of events 27
|
2.2%
19/868 • Number of events 22
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/879
|
0.35%
3/868 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.57%
5/879 • Number of events 16
|
0.58%
5/868 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness trunk
|
0.00%
0/879
|
0.12%
1/868 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.34%
3/879 • Number of events 7
|
0.12%
1/868 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.46%
4/879 • Number of events 7
|
0.35%
3/868 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.2%
46/879 • Number of events 73
|
5.1%
44/868 • Number of events 79
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.3%
29/879 • Number of events 58
|
4.4%
38/868 • Number of events 79
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
1.7%
15/879 • Number of events 20
|
0.58%
5/868 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.11%
1/879 • Number of events 3
|
0.12%
1/868 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.0%
114/879 • Number of events 318
|
10.6%
92/868 • Number of events 311
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis upper limb
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplasia
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.80%
7/879 • Number of events 7
|
0.69%
6/868 • Number of events 6
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.46%
4/879 • Number of events 4
|
0.35%
3/868 • Number of events 4
|
|
Nervous system disorders
Acoustic nerve disorder NOS
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Nervous system disorders
Arachnoiditis
|
0.11%
1/879 • Number of events 3
|
0.00%
0/868
|
|
Nervous system disorders
Ataxia
|
0.34%
3/879 • Number of events 3
|
0.12%
1/868 • Number of events 1
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
0.57%
5/879 • Number of events 5
|
0.35%
3/868 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
1.7%
15/879 • Number of events 30
|
1.8%
16/868 • Number of events 27
|
|
Nervous system disorders
Dysgeusia
|
0.23%
2/879 • Number of events 2
|
0.00%
0/868
|
|
Nervous system disorders
Encephalopathy
|
0.23%
2/879 • Number of events 2
|
0.12%
1/868 • Number of events 1
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.23%
2/879 • Number of events 2
|
0.12%
1/868 • Number of events 1
|
|
Nervous system disorders
Facial muscle weakness
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Nervous system disorders
Facial nerve disorder
|
0.34%
3/879 • Number of events 9
|
0.00%
0/868
|
|
Nervous system disorders
Headache
|
3.3%
29/879 • Number of events 58
|
4.3%
37/868 • Number of events 63
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.23%
2/879 • Number of events 2
|
0.69%
6/868 • Number of events 6
|
|
Nervous system disorders
Memory impairment
|
0.23%
2/879 • Number of events 4
|
0.12%
1/868 • Number of events 1
|
|
Nervous system disorders
Neuralgia
|
0.46%
4/879 • Number of events 8
|
0.81%
7/868 • Number of events 8
|
|
Nervous system disorders
Neurological disorder NOS
|
0.80%
7/879 • Number of events 10
|
0.35%
3/868 • Number of events 3
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.9%
17/879 • Number of events 33
|
1.3%
11/868 • Number of events 18
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.8%
33/879 • Number of events 91
|
5.9%
51/868 • Number of events 215
|
|
Nervous system disorders
Pyramidal tract syndrome
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Nervous system disorders
Radiculitis brachial
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Nervous system disorders
Seizure
|
0.00%
0/879
|
0.69%
6/868 • Number of events 7
|
|
Nervous system disorders
Sinus pain
|
0.11%
1/879 • Number of events 2
|
0.23%
2/868 • Number of events 2
|
|
Nervous system disorders
Speech disorder
|
0.23%
2/879 • Number of events 2
|
0.12%
1/868 • Number of events 1
|
|
Nervous system disorders
Syncope
|
1.6%
14/879 • Number of events 20
|
1.3%
11/868 • Number of events 15
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Nervous system disorders
Tremor
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
0.11%
1/879 • Number of events 10
|
0.00%
0/868
|
|
Psychiatric disorders
Anxiety
|
0.46%
4/879 • Number of events 6
|
0.46%
4/868 • Number of events 5
|
|
Psychiatric disorders
Confusion
|
0.46%
4/879 • Number of events 14
|
0.69%
6/868 • Number of events 6
|
|
Psychiatric disorders
Depression
|
0.46%
4/879 • Number of events 6
|
1.4%
12/868 • Number of events 25
|
|
Psychiatric disorders
Insomnia
|
0.68%
6/879 • Number of events 16
|
0.69%
6/868 • Number of events 11
|
|
Psychiatric disorders
Libido decreased
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Psychiatric disorders
Psychosis
|
0.23%
2/879 • Number of events 2
|
0.12%
1/868 • Number of events 1
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/879
|
0.23%
2/868 • Number of events 2
|
|
Renal and urinary disorders
Bladder stenosis
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Renal and urinary disorders
Cystitis
|
0.23%
2/879 • Number of events 2
|
0.12%
1/868 • Number of events 1
|
|
Renal and urinary disorders
Hemoglobin urine positive
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
0.23%
2/879 • Number of events 3
|
0.00%
0/868
|
|
Renal and urinary disorders
Kidney pain
|
0.34%
3/879 • Number of events 3
|
0.46%
4/868 • Number of events 4
|
|
Renal and urinary disorders
Kidney perforation
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/879
|
0.23%
2/868 • Number of events 2
|
|
Renal and urinary disorders
Renal failure
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.11%
1/879 • Number of events 1
|
0.23%
2/868 • Number of events 2
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/879
|
0.23%
2/868 • Number of events 2
|
|
Renal and urinary disorders
Urethral hemorrhage
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Renal and urinary disorders
Urethral obstruction
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
|
Renal and urinary disorders
Urinary frequency
|
0.11%
1/879 • Number of events 1
|
0.92%
8/868 • Number of events 13
|
|
Renal and urinary disorders
Urinary incontinence
|
0.46%
4/879 • Number of events 19
|
0.23%
2/868 • Number of events 4
|
|
Renal and urinary disorders
Urinary retention
|
0.46%
4/879 • Number of events 6
|
0.46%
4/868 • Number of events 4
|
|
Renal and urinary disorders
Urogenital disorder
|
20.8%
183/879 • Number of events 794
|
18.3%
159/868 • Number of events 677
|
|
Reproductive system and breast disorders
Breast pain
|
0.80%
7/879 • Number of events 42
|
1.2%
10/868 • Number of events 16
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/879
|
0.12%
1/868 • Number of events 3
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.6%
14/879 • Number of events 31
|
1.0%
9/868 • Number of events 12
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/879
|
0.12%
1/868 • Number of events 3
|
|
Reproductive system and breast disorders
Prostatic pain
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.23%
2/879 • Number of events 2
|
0.00%
0/868
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/879
|
0.12%
1/868 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.11%
1/879 • Number of events 2
|
0.23%
2/868 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.11%
1/879 • Number of events 5
|
0.00%
0/868
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.91%
8/879 • Number of events 8
|
1.4%
12/868 • Number of events 33
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.8%
42/879 • Number of events 71
|
5.9%
51/868 • Number of events 78
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.11%
1/879 • Number of events 1
|
0.35%
3/868 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.80%
7/879 • Number of events 8
|
1.6%
14/868 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal examination abnormal
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.46%
4/879 • Number of events 5
|
0.23%
2/868 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.80%
7/879 • Number of events 8
|
1.5%
13/868 • Number of events 30
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.11%
1/879 • Number of events 1
|
0.23%
2/868 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.34%
3/879 • Number of events 4
|
0.69%
6/868 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.11%
1/879 • Number of events 1
|
0.23%
2/868 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.11%
1/879 • Number of events 1
|
0.23%
2/868 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract hemorrhage
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.46%
4/879 • Number of events 11
|
0.46%
4/868 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.11%
1/879 • Number of events 1
|
0.23%
2/868 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/879
|
0.12%
1/868 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.11%
1/879 • Number of events 2
|
0.46%
4/868 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
1.4%
12/879 • Number of events 21
|
0.92%
8/868 • Number of events 39
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.11%
1/879 • Number of events 1
|
0.23%
2/868 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.23%
2/879 • Number of events 2
|
0.12%
1/868 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.23%
2/879 • Number of events 2
|
0.35%
3/868 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
0.80%
7/879 • Number of events 13
|
0.81%
7/868 • Number of events 19
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.46%
4/879 • Number of events 6
|
0.46%
4/868 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.23%
2/879 • Number of events 4
|
0.46%
4/868 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.23%
2/879 • Number of events 3
|
0.12%
1/868 • Number of events 13
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.11%
1/879 • Number of events 2
|
0.12%
1/868 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.34%
3/879 • Number of events 3
|
0.23%
2/868 • Number of events 2
|
|
Vascular disorders
Hematoma
|
0.00%
0/879
|
0.12%
1/868 • Number of events 1
|
|
Vascular disorders
Hemorrhage
|
0.00%
0/879
|
0.23%
2/868 • Number of events 2
|
|
Vascular disorders
Hot flashes
|
0.23%
2/879 • Number of events 2
|
1.0%
9/868 • Number of events 32
|
|
Vascular disorders
Hypertension
|
3.6%
32/879 • Number of events 75
|
2.4%
21/868 • Number of events 55
|
|
Vascular disorders
Hypotension
|
0.91%
8/879 • Number of events 9
|
1.4%
12/868 • Number of events 12
|
|
Vascular disorders
Peripheral ischemia
|
0.11%
1/879 • Number of events 1
|
0.00%
0/868
|
|
Vascular disorders
Thrombosis
|
2.6%
23/879 • Number of events 34
|
2.8%
24/868 • Number of events 47
|
|
Vascular disorders
Vascular disorder
|
0.11%
1/879 • Number of events 1
|
0.12%
1/868 • Number of events 1
|
Additional Information
Andrew L. Himelstein, MD
Christiana Care Health System
Phone: (302) 366-1200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60