Trial Outcomes & Findings for Study of Zoladex Given Every 12 Weeks Versus Given Every Month in Advanced Breast Cancer (ABC) Pre-menopausal Women (NCT NCT00322348)
NCT ID: NCT00322348
Last Updated: 2011-01-24
Results Overview
The number of participants for whom neither objective disease progression or death (due to any cause) has been observed at Week 24 over the number of randomised participants x 100.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
98 participants
Primary outcome timeframe
Objective tumour assessments carried out every 12 weeks (+/- 7 days) until Week 24, and then every 24 weeks (+/- 14 days) until Week 96 or objective progression is confirmed according to Response Evaluation Criteria in Solid Tumours (RECIST).
Results posted on
2011-01-24
Participant Flow
Pre-menopausal women with Oestrogen Receptor Positive Advanced Breast Cancer were recruited between 25th April 2006 and 24th December 2007. 49 participants were randomised to ZOLADEX 10.8 mg and 49 participants were randomised to ZOLADEX 3.6 mg. One participant was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg.
53 of the151 screened participants were not randomised to treatment groups for the following reasons : 50 participants were incorrectly enrolled (i.e. did not comply with inclusions/exclusion criteria) and a bone scan was not performed for 3 participants.
Participant milestones
| Measure |
ZOLADEX 10.8 mg
ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
|
ZOLADEX 3.6 mg
ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
49
|
|
Overall Study
Received Study Treatment
|
50
|
48
|
|
Overall Study
COMPLETED
|
12
|
16
|
|
Overall Study
NOT COMPLETED
|
37
|
33
|
Reasons for withdrawal
| Measure |
ZOLADEX 10.8 mg
ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
|
ZOLADEX 3.6 mg
ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Disease Progression
|
30
|
25
|
|
Overall Study
Reasons not specified
|
5
|
1
|
Baseline Characteristics
Study of Zoladex Given Every 12 Weeks Versus Given Every Month in Advanced Breast Cancer (ABC) Pre-menopausal Women
Baseline characteristics by cohort
| Measure |
ZOLADEX 10.8 mg
n=49 Participants
ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
|
ZOLADEX 3.6 mg
n=49 Participants
ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
42.0 Years
STANDARD_DEVIATION 6.45 • n=5 Participants
|
42.6 Years
STANDARD_DEVIATION 6.07 • n=7 Participants
|
42.3 Years
STANDARD_DEVIATION 6.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
27 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Oriental
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Objective tumour assessments carried out every 12 weeks (+/- 7 days) until Week 24, and then every 24 weeks (+/- 14 days) until Week 96 or objective progression is confirmed according to Response Evaluation Criteria in Solid Tumours (RECIST).The number of participants for whom neither objective disease progression or death (due to any cause) has been observed at Week 24 over the number of randomised participants x 100.
Outcome measures
| Measure |
ZOLADEX 10.8 mg
n=49 Participants
ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
|
ZOLADEX 3.6 mg
n=49 Participants
ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
|
|---|---|---|
|
Percentage of Participants With Progression Free Survival (PFS) at Week 24
|
69.4 Percentage of participants
|
73.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Response Evaluation Criteria in Solid Tumours (RECIST) tumour assessments carried out every 12 weeks from randomisation until Week 24 in those patients with measurable disease at baseline.Number of participants who were objective responders at Week 24 over the number of participants evaluable for response x 100. An objective responder = a participants whose best unconfirmed response is either CR (Complete Response Disappearance of all target lesions) or PR (Partial Response At least a 30% decrease in target lesions)
Outcome measures
| Measure |
ZOLADEX 10.8 mg
n=45 Participants
ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
|
ZOLADEX 3.6 mg
n=43 Participants
ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
|
|---|---|---|
|
Objective Response Rate (ORR) at Week 24
|
28.9 Percentage of participants
|
25.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Blood samples for measurement of E2 concentrations collected from all patients at scheduled visits of screening, Day 1 and Weeks 12 and 24 (+/- 7 days). Week 24 data is presentedA comparison of mean E2 serum concentrations at timepoint(s) post Day 1 performed using analysis of covariance (ANCOVA), with treatment group, baseline E2 serum concentrations and country as covariates. Data analysed on the log scale; log scale mean and pooled log scale standard deviation from Analysis of Covariance (ANCOVA) presented.
Outcome measures
| Measure |
ZOLADEX 10.8 mg
n=41 Participants
ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
|
ZOLADEX 3.6 mg
n=45 Participants
ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
|
|---|---|---|
|
Oestradiol (E2) Serum Concentrations at Week 24
|
1.42 pmol/L
Standard Deviation 0.99
|
1.49 pmol/L
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: Blood samples taken at Days 1, 2 and 3, Weeks 4, 12 and 24. Derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug for patients in the pharmacokinetic (PK) subgroupPopulation: participants in the pharmacokinetic (PK) subgroup
Maximum plasma concentration, Cmax (ng/mL), derived from analysis of pharmacokinetic (PK) outcomes samples provided only by participants in the PK subgroup set (all of whom received ZOLADEX 10.8 mg)
Outcome measures
| Measure |
ZOLADEX 10.8 mg
n=19 Participants
ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
|
ZOLADEX 3.6 mg
ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
|
|---|---|---|
|
Maximum Plasma Concentration, Cmax (ng/mL)
|
4.565 ng/mL
Interval 0.501 to 14.0
|
—
|
SECONDARY outcome
Timeframe: Blood samples taken at Days 1, 2 and 3, Weeks 4, 12 and 24. Derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug for patients in the pharmacokinetic (PK) subgroupPopulation: participants in the PK subgroup set
Time to maximum plasma concentration, Tmax (hours), derived from analysis of pharmacokinetic (PK) outcomes samples provided only by participants in the PK subgroup set (all of whom received ZOLADEX 10.8 mg)
Outcome measures
| Measure |
ZOLADEX 10.8 mg
n=19 Participants
ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
|
ZOLADEX 3.6 mg
ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
|
|---|---|---|
|
Time to Maximum Plasma Concentration, Tmax (Hours)
|
1.9 hours
Interval 1.0 to 24.0
|
—
|
SECONDARY outcome
Timeframe: Blood samples taken at Days 1, 2 and 3, Weeks 4, 12 and 24. Derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug for patients in the pharmacokinetic (PK) subgroupPopulation: participants in the PK subgroup set
Area under the plasma concentration curve (0-12 weeks) derived from analysis of pharmacokinetic (PK) outcomes samples provided only by participants in the PK subgroup set (all of whom received ZOLADEX 10.8 mg)
Outcome measures
| Measure |
ZOLADEX 10.8 mg
n=19 Participants
ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
|
ZOLADEX 3.6 mg
ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
|
|---|---|---|
|
Area Under the Plasma Concentration Curve (0-12 Weeks)
|
33.021 ng/mL
Interval 9.13 to 73.7
|
—
|
Adverse Events
ZOLADEX 10.8 mg
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
ZOLADEX 3.6 mg
Serious events: 3 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ZOLADEX 10.8 mg
n=50 participants at risk
ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
|
ZOLADEX 3.6 mg
n=48 participants at risk
ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
|
|---|---|---|
|
Infections and infestations
Peritonsillar Abscess
|
0.00%
0/50
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
2.1%
1/48
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
2.0%
1/50
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
0.00%
0/48
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
|
Reproductive system and breast disorders
Endometrial Hyperplasia
|
2.0%
1/50
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
2.1%
1/48
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
|
Vascular disorders
Haematoma
|
0.00%
0/50
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
2.1%
1/48
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
Other adverse events
| Measure |
ZOLADEX 10.8 mg
n=50 participants at risk
ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
|
ZOLADEX 3.6 mg
n=48 participants at risk
ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/50
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
6.2%
3/48
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
|
Gastrointestinal disorders
Nausea
|
6.0%
3/50
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
8.3%
4/48
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/50
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
6.2%
3/48
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/50
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
6.2%
3/48
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
|
General disorders
Fatigue
|
0.00%
0/50
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
8.3%
4/48
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
|
General disorders
Pyrexia
|
2.0%
1/50
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
8.3%
4/48
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
|
General disorders
Asthenia
|
2.0%
1/50
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
6.2%
3/48
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
|
Infections and infestations
Nasopharyngitis
|
22.0%
11/50
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
10.4%
5/48
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
6.0%
3/50
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
4.2%
2/48
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
|
Infections and infestations
Weight Increased
|
14.0%
7/50
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
16.7%
8/48
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.0%
2/50
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
8.3%
4/48
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.0%
1/50
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
6.2%
3/48
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
|
Nervous system disorders
Headache
|
8.0%
4/50
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
6.2%
3/48
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
|
Reproductive system and breast disorders
Amenorrhoea
|
26.0%
13/50
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
22.9%
11/48
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/50
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
8.3%
4/48
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/50
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
6.2%
3/48
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
|
Vascular disorders
Hot Flush
|
38.0%
19/50
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
37.5%
18/48
49 participants were randomised to ZOLADEX 10.8 mg and 49 patients were randomised to ZOLADEX 3.6 mg. One patient was randomised to ZOLADEX 3.6 mg but received ZOLADEX 10.8 mg. therefore 50 participants included in ZOLADEX 10.8 mg and 48 in ZOLADEX 3.6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There is an agreement between the Principal Investigator and the Sponsor (or its agents). The only disclosure restriction on the PI is that they cannot disclose or publish any information to do with the trial without consent from AstraZeneca.
- Publication restrictions are in place
Restriction type: OTHER