Trial Outcomes & Findings for Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects With Metastatic Bone Disease (NCT NCT00558272)
NCT ID: NCT00558272
Last Updated: 2013-05-27
Results Overview
Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.
COMPLETED
PHASE2
139 participants
Baseline to Week 4
2013-05-27
Participant Flow
Randomised=full analysis set: AZD0530 175mg=69, Zoledronic acid 4mg=70; safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
Participant milestones
| Measure |
AZD0530 175 mg
AZD0530 (saracatinib) 175 mg once daily
|
Zoledronic Acid 4 mg
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
70
|
|
Overall Study
30 Days Follow-up
|
41
|
67
|
|
Overall Study
COMPLETED
|
56
|
68
|
|
Overall Study
NOT COMPLETED
|
13
|
2
|
Reasons for withdrawal
| Measure |
AZD0530 175 mg
AZD0530 (saracatinib) 175 mg once daily
|
Zoledronic Acid 4 mg
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Dev. of study specific discon. criteria
|
1
|
0
|
|
Overall Study
AZ study team decision
|
0
|
1
|
|
Overall Study
Incorrectly enrolled
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects With Metastatic Bone Disease
Baseline characteristics by cohort
| Measure |
AZD0530 175 mg
n=69 Participants
AZD0530 (saracatinib) 175 mg once daily
|
Zoledronic Acid 4 mg
n=70 Participants
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
67.6 Years
STANDARD_DEVIATION 8.35 • n=5 Participants
|
67.3 Years
STANDARD_DEVIATION 11.58 • n=7 Participants
|
67.4 Years
STANDARD_DEVIATION 10.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 4Population: The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.
Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.
Outcome measures
| Measure |
AZD0530 175 mg
n=46 Participants
AZD0530 (saracatinib) 175 mg once daily
|
Zoledronic Acid 4 mg
n=65 Participants
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
|
|---|---|---|
|
Percentage Change From Baseline in Serum Beta C-terminal Cross-linking Telopeptide of Type I Collagen (betaCTX) at Week 4
|
-71.1 Percentage change in betaCTX
Interval -75.9 to -65.4
|
-68.4 Percentage change in betaCTX
Interval -73.0 to -63.2
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.
Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.
Outcome measures
| Measure |
AZD0530 175 mg
n=48 Participants
AZD0530 (saracatinib) 175 mg once daily
|
Zoledronic Acid 4 mg
n=66 Participants
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
|
|---|---|---|
|
Percentage Change From Baseline in Serum Bone-specific Alkaline Phosphatase (bALP) at Week 4
|
-13.2 Percentage change in bALP
Interval -24.4 to -0.3
|
-3.1 Percentage change in bALP
Interval -13.9 to 9.1
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.
Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.
Outcome measures
| Measure |
AZD0530 175 mg
n=47 Participants
AZD0530 (saracatinib) 175 mg once daily
|
Zoledronic Acid 4 mg
n=66 Participants
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
|
|---|---|---|
|
Percentage Change From Baseline in Serum Cross-linked C-terminal Telopeptide of Type I Collagen (ICTP) at Week 4
|
-40.2 Percentage change in ICTP
Interval -46.3 to -33.4
|
7.4 Percentage change in ICTP
Interval -2.0 to 17.7
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.
Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.
Outcome measures
| Measure |
AZD0530 175 mg
n=48 Participants
AZD0530 (saracatinib) 175 mg once daily
|
Zoledronic Acid 4 mg
n=66 Participants
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
|
|---|---|---|
|
Percentage Change From Baseline in Serum N-terminal Propeptide of Type I Procollagen (PINP) at Week 4
|
-26.1 Percentage change in PINP
Interval -36.0 to -14.7
|
-29.5 Percentage change in PINP
Interval -37.7 to -20.3
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.
Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.
Outcome measures
| Measure |
AZD0530 175 mg
n=48 Participants
AZD0530 (saracatinib) 175 mg once daily
|
Zoledronic Acid 4 mg
n=65 Participants
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
|
|---|---|---|
|
Percentage Change From Baseline in Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) at Week 4
|
-36.9 Percentage change in TRAP5b
Interval -42.7 to -30.4
|
-43.4 Percentage change in TRAP5b
Interval -48.0 to -38.4
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.
Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.
Outcome measures
| Measure |
AZD0530 175 mg
n=46 Participants
AZD0530 (saracatinib) 175 mg once daily
|
Zoledronic Acid 4 mg
n=62 Participants
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
|
|---|---|---|
|
Percentage Change From Baseline in Urine N-terminal Cross-linking Telopeptide of Type I Collagen Normalised to Creatinine (NTx/Cr) at Week 4
|
-57.2 Percentage change in NTx/Cr
Interval -65.7 to -46.6
|
-70.1 Percentage change in NTx/Cr
Interval -75.4 to -63.8
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.
Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.
Outcome measures
| Measure |
AZD0530 175 mg
n=41 Participants
AZD0530 (saracatinib) 175 mg once daily
|
Zoledronic Acid 4 mg
n=49 Participants
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
|
|---|---|---|
|
Percentage Change From Baseline in Urine Alpha-alpha C-terminal Cross-linking Telopeptide of Type I Collagen Normalised to Creatinine (aaCTx/Cr) at Week 4
|
-68.2 Percentage change in aaCTx/Cr
Interval -76.7 to -56.5
|
-82.8 Percentage change in aaCTx/Cr
Interval -87.1 to -77.0
|
SECONDARY outcome
Timeframe: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29Previous studies have shown that saracatinib reduces osteoclast function and bone resorption. Bone turnover, the combined result of bone formation and bone resorption, can be assessed in real time by measuring specific markers of bone turnover in serum and in urine. These markers were assessed in a study of patients with metastatic bone disease treated with saracatinib. Specific assays are available to quantitate these markers in serum and urine. In this study the effects of saracatinib on bone turnover were compared with the effects of zoledronic acid, a marketed drug known to inhibit bone resorption in cancer patients with bone metastatses.
Outcome measures
| Measure |
AZD0530 175 mg
n=51 Participants
AZD0530 (saracatinib) 175 mg once daily
|
Zoledronic Acid 4 mg
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
|
|---|---|---|
|
Saracatinib: Area Under the Curve at Steady State (AUCss)
|
7261 ng•hr/ml
Interval 3960.0 to 21500.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29Outcome measures
| Measure |
AZD0530 175 mg
n=51 Participants
AZD0530 (saracatinib) 175 mg once daily
|
Zoledronic Acid 4 mg
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
|
|---|---|---|
|
Saracatinib: Plasma Clearance at Steady State (CLss/F)
|
24.10 L/h
Interval 8.15 to 44.2
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29Outcome measures
| Measure |
AZD0530 175 mg
n=51 Participants
AZD0530 (saracatinib) 175 mg once daily
|
Zoledronic Acid 4 mg
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
|
|---|---|---|
|
Saracatinib: Maximum Plasma Concentration at Steady State (Css,Max)
|
396.0 ng/ml
Interval 190.0 to 1170.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29Outcome measures
| Measure |
AZD0530 175 mg
n=51 Participants
AZD0530 (saracatinib) 175 mg once daily
|
Zoledronic Acid 4 mg
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
|
|---|---|---|
|
Saracatinib: Minimum Plasma Concentration at Steady State (Css,Min)
|
229.0 ng/ml
Interval 99.1 to 770.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29Outcome measures
| Measure |
AZD0530 175 mg
n=51 Participants
AZD0530 (saracatinib) 175 mg once daily
|
Zoledronic Acid 4 mg
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
|
|---|---|---|
|
Saracatinib: Time to Cssmax (Tmax)
|
4.0 h
Interval 2.0 to 9.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29Outcome measures
| Measure |
AZD0530 175 mg
n=51 Participants
AZD0530 (saracatinib) 175 mg once daily
|
Zoledronic Acid 4 mg
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
|
|---|---|---|
|
N-desmethyl Metabolite of Saracatinib: Area Under the Curve at Steady State (AUCss)
|
1069 ng.h/ml
Interval 529.0 to 5100.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29Outcome measures
| Measure |
AZD0530 175 mg
n=51 Participants
AZD0530 (saracatinib) 175 mg once daily
|
Zoledronic Acid 4 mg
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
|
|---|---|---|
|
N-desmethyl Metabolite of Saracatinib: Maximum Plasma Concentration at Steady State (Css,Max)
|
62.80 ng/ml
Interval 25.3 to 253.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29Outcome measures
| Measure |
AZD0530 175 mg
n=51 Participants
AZD0530 (saracatinib) 175 mg once daily
|
Zoledronic Acid 4 mg
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
|
|---|---|---|
|
N-desmethyl Metabolite of Saracatinib: Minimum Plasma Concentration at Steady State (Css,Min)
|
34.30 ng/ml
Interval 16.6 to 230.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29Outcome measures
| Measure |
AZD0530 175 mg
n=51 Participants
AZD0530 (saracatinib) 175 mg once daily
|
Zoledronic Acid 4 mg
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
|
|---|---|---|
|
N-desmethyl Metabolite of Saracatinib: AUCss Metabolite to Parent Ratio
|
0.1420 Ratio
Interval 0.081 to 0.354
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on days 8, 15, 29; 2 hours, 4 hours, 6 hours, 9 hours post dose on day 29Outcome measures
| Measure |
AZD0530 175 mg
n=51 Participants
AZD0530 (saracatinib) 175 mg once daily
|
Zoledronic Acid 4 mg
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
|
|---|---|---|
|
N-desmethyl Metabolite of Saracatinib: Time to Cssmax (Tmax)
|
2.0 h
Interval 2.0 to 9.0
|
—
|
Adverse Events
AZD0530 175 mg
Zoledronic Acid 4 mg
Serious adverse events
| Measure |
AZD0530 175 mg
n=68 participants at risk
AZD0530 (saracatinib) 175 mg once daily
|
Zoledronic Acid 4 mg
n=69 participants at risk
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
1/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
0.00%
0/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Cardiac disorders
Cardiac Arrest
|
1.5%
1/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
0.00%
0/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Cardiac disorders
Myocardial Infarction
|
1.5%
1/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
0.00%
0/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
0.00%
0/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
1.4%
1/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
General disorders
Pyrexia
|
1.5%
1/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
0.00%
0/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Infections and infestations
Pneumonia
|
2.9%
2/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
0.00%
0/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Infections and infestations
Viral Infection
|
1.5%
1/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
0.00%
0/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Injury, poisoning and procedural complications
Blood Creatinine Increased
|
0.00%
0/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
1.4%
1/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
1.4%
1/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
1.4%
1/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
1.4%
1/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
1.4%
1/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Nervous system disorders
Cerebral Haemorrhage
|
1.5%
1/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
0.00%
0/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Renal and urinary disorders
Renal Failure
|
1.5%
1/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
0.00%
0/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.5%
1/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
0.00%
0/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
1.5%
1/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
0.00%
0/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.5%
1/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
0.00%
0/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
Other adverse events
| Measure |
AZD0530 175 mg
n=68 participants at risk
AZD0530 (saracatinib) 175 mg once daily
|
Zoledronic Acid 4 mg
n=69 participants at risk
Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
23.5%
16/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
4.3%
3/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Gastrointestinal disorders
Diarrhoea
|
19.1%
13/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
5.8%
4/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Gastrointestinal disorders
Constipation
|
14.7%
10/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
7.2%
5/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Gastrointestinal disorders
Vomiting
|
10.3%
7/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
7.2%
5/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
General disorders
Influenza Like Illness
|
4.4%
3/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
11.6%
8/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
General disorders
Pyrexia
|
5.9%
4/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
8.7%
6/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
General disorders
Fatigue
|
7.4%
5/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
5.8%
4/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
General disorders
Asthenia
|
5.9%
4/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
1.4%
1/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
General disorders
Oedema Peripheral
|
5.9%
4/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
2.9%
2/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Infections and infestations
Influenza
|
0.00%
0/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
15.9%
11/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Infections and infestations
Urinary Tract Infection
|
8.8%
6/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
2.9%
2/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
11.8%
8/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
1.4%
1/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
1.5%
1/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
10.1%
7/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.8%
8/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
5.8%
4/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
7.4%
5/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
11.6%
8/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
4/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
10.1%
7/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
4.4%
3/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
7.2%
5/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
1.5%
1/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
5.8%
4/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Nervous system disorders
Headache
|
7.4%
5/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
7.2%
5/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.4%
5/68
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
2.9%
2/69
safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a Study Site, or an investigator, requests permission to publish data from this study, any such publication (including oral presentations) is to be agreed with AstraZeneca prior to publication.
- Publication restrictions are in place
Restriction type: OTHER