Trial Outcomes & Findings for Zoledronate, Vitamin D, and Calcium With or Without Strontium 89 or Samarium 153 in Preventing or Delaying Bone Problems in Patients With Bone Metastases From Prostate Cancer, Lung Cancer, or Breast Cancer (NCT NCT00365105)
NCT ID: NCT00365105
Last Updated: 2024-09-20
Results Overview
Median time to development of a malignant skeletal related event (SRE), which is defined as a pathological bone fracture, spinal cord compression, surgery to bone or radiation to bone is estimated using Kaplan-Meier method. The time of failure was measured from date of randomization to the date of a documented SRE. The analysis was planned to occur after 257 SRE have been observed, unless the criteria for early stopping are met.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
261 participants
Primary outcome timeframe
From randomization to last follow-up. Maximum follow-up at time of analysis was 80.1 months.
Results posted on
2024-09-20
Participant Flow
Participant milestones
| Measure |
Zoledronic Acid
Zoledronic acid, vitamin D and calcium supplements.
|
Zoledronic Acid + Radiopharmaceuticals
Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
|
|---|---|---|
|
Overall Study
STARTED
|
129
|
132
|
|
Overall Study
Eligible
|
124
|
124
|
|
Overall Study
Eligible With Adverse Event Data
|
123
|
124
|
|
Overall Study
COMPLETED
|
124
|
124
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
| Measure |
Zoledronic Acid
Zoledronic acid, vitamin D and calcium supplements.
|
Zoledronic Acid + Radiopharmaceuticals
Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
5
|
8
|
Baseline Characteristics
Zoledronate, Vitamin D, and Calcium With or Without Strontium 89 or Samarium 153 in Preventing or Delaying Bone Problems in Patients With Bone Metastases From Prostate Cancer, Lung Cancer, or Breast Cancer
Baseline characteristics by cohort
| Measure |
Zoledronic Acid
n=124 Participants
Zoledronic acid, vitamin D and calcium supplements.
|
Zoledronic Acid + Radiopharmaceuticals
n=124 Participants
Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
|
Total
n=248 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
68 years
n=7 Participants
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 80.1 months.Population: Eligible patients
Median time to development of a malignant skeletal related event (SRE), which is defined as a pathological bone fracture, spinal cord compression, surgery to bone or radiation to bone is estimated using Kaplan-Meier method. The time of failure was measured from date of randomization to the date of a documented SRE. The analysis was planned to occur after 257 SRE have been observed, unless the criteria for early stopping are met.
Outcome measures
| Measure |
Zoledronic Acid
n=124 Participants
Zoledronic acid, vitamin D and calcium supplements.
|
Zoledronic Acid + Radiopharmaceuticals
n=124 Participants
Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
|
|---|---|---|
|
Time to Development of a Malignant Skeletal-related Events (SRE)
|
29.9 months
Interval 25.8 to 37.4
|
27.4 months
Interval 21.2 to 35.34
|
SECONDARY outcome
Timeframe: From randomization to 1 yearPopulation: Eligible patients
Skeletal-related events are defined as a pathological bone fracture, spinal cord compression, surgery to bone or radiation to bone.
Outcome measures
| Measure |
Zoledronic Acid
n=124 Participants
Zoledronic acid, vitamin D and calcium supplements.
|
Zoledronic Acid + Radiopharmaceuticals
n=124 Participants
Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
|
|---|---|---|
|
Number of Patients Experiencing a Skeletal-related Event (SRE) Within One Year
|
28 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: From randomization to last follow-up. Maximum follow-up at time of analysis was 101.7 months.Population: Eligible patients
Overall survival time is defined as time from randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Outcome measures
| Measure |
Zoledronic Acid
n=124 Participants
Zoledronic acid, vitamin D and calcium supplements.
|
Zoledronic Acid + Radiopharmaceuticals
n=124 Participants
Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
|
|---|---|---|
|
Overall Survival
|
32.1 months
Interval 22.1 to 37.5
|
26.9 months
Interval 20.4 to 33.6
|
SECONDARY outcome
Timeframe: Baseline and 1 yearPopulation: Eligible patients with FACT-G scores at baseline and one year
The FACT-G is a validated 27-item measure in which a higher score represents higher quality of life (QOL). Physical, functional, social and emotional well-being subscale scores are added together to form the FACT-G total score. Responses range from 0=Not a lot to 4=Very much. Certain items must be reversed before being added, by subtracting the response from 4. Subscale items are added together, multiplied by the number of items in the subscale, then divided by the number of items answered to obtain subscale totals. Total score ranges from 0-108; physical, social and functional subscales from 0-28; emotional subscale from 0-24. Each subscale requires at least 50% of the items to be completed while the overall response rate must be greater than 80%. If items are missing the subscale scores can be prorated. Change score at one year is calculated as one year score - baseline score with a positive change score indicating improvement in QOL.
Outcome measures
| Measure |
Zoledronic Acid
n=62 Participants
Zoledronic acid, vitamin D and calcium supplements.
|
Zoledronic Acid + Radiopharmaceuticals
n=59 Participants
Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
|
|---|---|---|
|
Change in Functional Assessment of Cancer Therapy - General (FACT-G) at One Year
FACT-G Total
|
-1 units on a scale
Interval -8.0 to 5.0
|
-2 units on a scale
Interval -11.0 to 4.0
|
|
Change in Functional Assessment of Cancer Therapy - General (FACT-G) at One Year
Physical Well-Being
|
-1 units on a scale
Interval -4.0 to 1.0
|
-1 units on a scale
Interval -4.0 to 2.0
|
|
Change in Functional Assessment of Cancer Therapy - General (FACT-G) at One Year
Social/Family Well-Being
|
0 units on a scale
Interval -1.0 to 2.0
|
0 units on a scale
Interval -2.0 to 2.0
|
|
Change in Functional Assessment of Cancer Therapy - General (FACT-G) at One Year
Emotional Well-Being
|
0 units on a scale
Interval -1.0 to 3.0
|
0 units on a scale
Interval -2.0 to 2.0
|
|
Change in Functional Assessment of Cancer Therapy - General (FACT-G) at One Year
Functional Well-Being
|
0 units on a scale
Interval -4.0 to 2.0
|
0 units on a scale
Interval -4.0 to 1.0
|
SECONDARY outcome
Timeframe: Baseline and 1 yearPopulation: Eligible patients with baseline and one-year BPI score
The Brief Pain Inventory (BPI) is a measurement tool for assessing clinical pain. The BPI assesses severity (pain at its "worst," "least," "average," and "now"), and interference (how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep). Patients rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function on a scale of 0 to 10, with 0=no pain/interference and 10=interferes completely/worst pain imaginable.
Outcome measures
| Measure |
Zoledronic Acid
n=54 Participants
Zoledronic acid, vitamin D and calcium supplements.
|
Zoledronic Acid + Radiopharmaceuticals
n=51 Participants
Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
|
|---|---|---|
|
Change in Brief Pain Inventory (BPI) at One Year
|
1 units on a scale
Interval -5.0 to 9.0
|
0 units on a scale
Interval -6.0 to 7.0
|
SECONDARY outcome
Timeframe: Baseline and 1 yearPopulation: Eligible patients with EQ-5D-3L scores at baseline and one year
The EQ-5D-3L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Change at one year is calculated as one-year score - baseline score with positive change indicating improved quality of life.
Outcome measures
| Measure |
Zoledronic Acid
n=53 Participants
Zoledronic acid, vitamin D and calcium supplements.
|
Zoledronic Acid + Radiopharmaceuticals
n=51 Participants
Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
|
|---|---|---|
|
Change in EuroQol-5 Dimension 3-level (EQ-5D-3L) at One Year
VAS Score
|
-1.20 units on a scale
Standard Deviation 20.43
|
-6.70 units on a scale
Standard Deviation 15.70
|
|
Change in EuroQol-5 Dimension 3-level (EQ-5D-3L) at One Year
Index Score
|
-0.04 units on a scale
Standard Deviation 0.14
|
-0.06 units on a scale
Standard Deviation 0.15
|
Adverse Events
Zoledronic Acid
Serious events: 31 serious events
Other events: 102 other events
Deaths: 0 deaths
Zoledronic Acid + Radiopharmaceuticals
Serious events: 37 serious events
Other events: 108 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zoledronic Acid
n=123 participants at risk
Zoledronic acid, vitamin D and calcium supplements.
|
Zoledronic Acid + Radiopharmaceuticals
n=124 participants at risk
Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood/bone marrow - Other:
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
4.9%
6/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.1%
10/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Atrial fibrillation
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.6%
2/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Cardiac General - Other:
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Pericardial effusion
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.6%
2/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Eye disorders
Diplopia
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
1.6%
2/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Colonic perforation
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Gastrointestinal - Other:
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Ileal haemorrhage
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
2/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Small intestinal stricture NOS
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Vomiting NOS
|
1.6%
2/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.6%
2/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Chest pain
|
1.6%
2/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Death NOS
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Disease progression NOS
|
2.4%
3/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.6%
2/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Edema: limb:
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fatigue
|
3.3%
4/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Gait abnormal NOS
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Pain NOS
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Abdominal infection
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Bladder infection NOS
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Bone infection NOS
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Bronchitis NOS
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection - Other:
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Bladder (urinary)
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Catheter-related
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Lung (pneumonia)
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Pleura (empyema)
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Infection with unknown ANC: Urinary tract NOS
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Pneumonia NOS
|
1.6%
2/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.6%
2/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Sepsis NOS
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Skin infection
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Wound infection
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Fracture NOS
|
1.6%
2/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.4%
3/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Blood creatinine increased
|
3.3%
4/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.4%
3/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Leukopenia NOS
|
1.6%
2/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Lymphopenia
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Metabolic/laboratory - Other:
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Neutrophil count
|
1.6%
2/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.6%
2/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Platelet count decreased
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.6%
7/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Prothrombin time prolonged
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Troponin T increased
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
4/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.2%
4/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycaemia NOS
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.6%
2/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.6%
2/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.6%
2/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.6%
2/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.6%
2/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.6%
2/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.6%
2/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness NOS
|
1.6%
2/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.6%
2/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis NOS
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.6%
2/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Ataxia
|
1.6%
2/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.6%
2/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dizziness
|
2.4%
3/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Headache
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Neurology - Other:
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.6%
2/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.4%
3/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Confusional state
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Bladder obstruction
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Renal failure NOS
|
1.6%
2/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Renal/genitourinary - Other:
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urethral obstruction
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.6%
2/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.1%
5/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.4%
3/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.4%
3/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.81%
1/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.6%
2/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis NOS
|
4.1%
5/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.6%
2/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/upper respiratory - Other:
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.6%
2/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Ulceration:
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
0.00%
0/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Hypotension NOS
|
4.1%
5/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.6%
2/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.6%
2/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
Other adverse events
| Measure |
Zoledronic Acid
n=123 participants at risk
Zoledronic acid, vitamin D and calcium supplements.
|
Zoledronic Acid + Radiopharmaceuticals
n=124 participants at risk
Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
45.5%
56/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
58.9%
73/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Eye disorders
Ocular/visual - Other:
|
4.9%
6/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.4%
3/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Abdominal pain NOS
|
6.5%
8/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.3%
9/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Constipation
|
23.6%
29/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
21.0%
26/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
15.4%
19/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.5%
18/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dry mouth
|
1.6%
2/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.8%
6/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
7/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.4%
3/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Nausea
|
24.4%
30/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.0%
31/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Stomatitis
|
5.7%
7/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.3%
9/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Gastrointestinal disorders
Vomiting NOS
|
9.8%
12/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.3%
19/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Chest pain
|
8.9%
11/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.6%
2/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Disease progression NOS
|
3.3%
4/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.8%
6/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Edema: limb:
|
22.8%
28/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
20.2%
25/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Fatigue
|
55.3%
68/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
62.1%
77/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Pain - Other:
|
10.6%
13/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.5%
8/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Pain NOS
|
8.1%
10/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.2%
4/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
General disorders
Pyrexia
|
4.1%
5/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.6%
7/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Pneumonia NOS
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.8%
6/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Infections and infestations
Respiratory tract infection NOS
|
0.81%
1/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.8%
6/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Ecchymosis
|
1.6%
2/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.6%
7/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Injury, poisoning and procedural complications
Fracture NOS
|
4.9%
6/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.2%
4/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Alanine aminotransferase increased
|
9.8%
12/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.3%
14/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Aspartate aminotransferase increased
|
18.7%
23/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
16.9%
21/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Blood alkaline phosphatase increased
|
25.2%
31/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
21.8%
27/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Blood bilirubin increased
|
5.7%
7/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.0%
5/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Blood creatinine increased
|
25.2%
31/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
22.6%
28/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Leukopenia NOS
|
21.1%
26/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
33.9%
42/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Lymphopenia
|
10.6%
13/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.5%
13/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Neutrophil count
|
12.2%
15/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.8%
32/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Platelet count decreased
|
15.4%
19/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
41.9%
52/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Weight decreased
|
13.0%
16/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
17.7%
22/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Investigations
Weight increased
|
1.6%
2/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.5%
8/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Anorexia
|
18.7%
23/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
23.4%
29/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.5%
8/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.0%
5/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
8.1%
10/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.2%
4/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycaemia NOS
|
30.9%
38/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.8%
32/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.1%
10/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.3%
9/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
21.1%
26/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
16.1%
20/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
13.8%
17/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
21.0%
26/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.5%
8/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.5%
13/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
13.0%
16/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
12.9%
16/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.3%
25/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
23.4%
29/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Arthritis NOS
|
4.9%
6/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.8%
6/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
31.7%
39/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
29.8%
37/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
32.5%
40/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
37.1%
46/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness NOS
|
7.3%
9/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
8.1%
10/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower
|
4.9%
6/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.6%
7/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue - Other:
|
2.4%
3/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.5%
8/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.8%
12/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
9.7%
12/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.3%
9/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.5%
8/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.6%
18/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
16.1%
20/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dizziness
|
17.1%
21/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.5%
18/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Dysgeusia
|
6.5%
8/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
2.4%
3/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Headache
|
12.2%
15/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.3%
14/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.7%
7/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.6%
2/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
18.7%
23/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
14.5%
18/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Anxiety
|
4.9%
6/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
7.3%
9/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Depression
|
8.9%
11/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
9.7%
12/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Psychiatric disorders
Insomnia
|
9.8%
12/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
15.3%
19/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Pollakiuria
|
7.3%
9/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
11.3%
14/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Renal/genitourinary - Other:
|
3.3%
4/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.8%
6/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary incontinence
|
6.5%
8/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.8%
6/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Renal and urinary disorders
Urinary retention
|
4.1%
5/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.6%
7/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Reproductive system and breast disorders
Pelvic pain NOS
|
6.5%
8/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.0%
5/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.8%
17/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
10.5%
13/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
21.1%
26/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
25.8%
32/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/upper respiratory - Other:
|
3.3%
4/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
6.5%
8/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.5%
8/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
9.7%
12/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative NOS
|
5.7%
7/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
1.6%
2/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Dermatology/skin - Other:
|
7.3%
9/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.8%
6/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Skin and subcutaneous tissue disorders
Localised exfoliation
|
3.3%
4/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
4.8%
6/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Hot flushes NOS
|
13.0%
16/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
13.7%
17/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Hypertension NOS
|
4.9%
6/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
3.2%
4/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
|
Vascular disorders
Hypotension NOS
|
3.3%
4/123
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
5.6%
7/124
Eligible patients with adverse event data. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER