Trial Outcomes & Findings for Study of Faslodex +/- Concomitant Arimidex v Exemestane Following Progression on Non-steroidal Aromatase Inhibitors (NCT NCT00253422)
NCT ID: NCT00253422
Last Updated: 2025-06-04
Results Overview
defined as time from randomisation to progression of existing disease, new sites of disease, second primary cancer if change in systemic treatment was necessary, or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
698 participants
Primary outcome timeframe
Assessed up to 190 months
Results posted on
2025-06-04
Participant Flow
Patients were recruited between 26 March 2004 and 6 August 2010 from 82 hospitals in the UK.
Prior to randomisation patients were assessed for medical history and had a clinical examination, haematology and biochemistry and tumour staging to assess eligibility.
Participant milestones
| Measure |
Faslodex + Placebo
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Placebo orally once a day
|
Faslodex + Arimidex
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Arimidex (anastrozole) orally once a day
|
Exemestane
exemestane orally once a day
Exemestane
|
|---|---|---|---|
|
Overall Study
STARTED
|
226
|
233
|
239
|
|
Overall Study
COMPLETED
|
226
|
233
|
238
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Faslodex + Placebo
n=226 Participants
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Placebo orally once a day
Anastrozole: This may be Anastrazole OR a placebo
Fulvestrant
|
Faslodex + Arimidex
n=233 Participants
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Arimidex (anastrozole) orally once a day
Anastrozole: This may be Anastrazole OR a placebo
Fulvestrant
|
Exemestane
n=239 Participants
exemestane orally once a day
Exemestane
|
Total
n=698 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.2 years
n=226 Participants
|
64.1 years
n=233 Participants
|
66.1 years
n=239 Participants
|
64.7 years
n=698 Participants
|
|
Age, Customized
<50 years
|
17 Participants
n=226 Participants
|
21 Participants
n=233 Participants
|
7 Participants
n=239 Participants
|
45 Participants
n=698 Participants
|
|
Age, Customized
50 to 64 years
|
102 Participants
n=226 Participants
|
104 Participants
n=233 Participants
|
100 Participants
n=239 Participants
|
306 Participants
n=698 Participants
|
|
Age, Customized
65 to 74 years
|
61 Participants
n=226 Participants
|
65 Participants
n=233 Participants
|
70 Participants
n=239 Participants
|
196 Participants
n=698 Participants
|
|
Age, Customized
>=75 years
|
46 Participants
n=226 Participants
|
43 Participants
n=233 Participants
|
62 Participants
n=239 Participants
|
151 Participants
n=698 Participants
|
|
Sex: Female, Male
Female
|
226 Participants
n=226 Participants
|
233 Participants
n=233 Participants
|
239 Participants
n=239 Participants
|
698 Participants
n=698 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=226 Participants
|
0 Participants
n=233 Participants
|
0 Participants
n=239 Participants
|
0 Participants
n=698 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
226 participants
n=226 Participants
|
233 participants
n=233 Participants
|
239 participants
n=239 Participants
|
698 participants
n=698 Participants
|
|
Hormone Receptor Status of primary disease
ER+ve PR+ve
|
121 Participants
n=226 Participants
|
111 Participants
n=233 Participants
|
123 Participants
n=239 Participants
|
355 Participants
n=698 Participants
|
|
Hormone Receptor Status of primary disease
ER+ve PR -ve
|
31 Participants
n=226 Participants
|
38 Participants
n=233 Participants
|
22 Participants
n=239 Participants
|
91 Participants
n=698 Participants
|
|
Hormone Receptor Status of primary disease
ER+ve PR unknown
|
71 Participants
n=226 Participants
|
83 Participants
n=233 Participants
|
91 Participants
n=239 Participants
|
245 Participants
n=698 Participants
|
|
Hormone Receptor Status of primary disease
ER-ve/unknown PR+ve
|
0 Participants
n=226 Participants
|
1 Participants
n=233 Participants
|
2 Participants
n=239 Participants
|
3 Participants
n=698 Participants
|
|
Hormone Receptor Status of primary disease
ER unknown PR unknown
|
2 Participants
n=226 Participants
|
0 Participants
n=233 Participants
|
1 Participants
n=239 Participants
|
3 Participants
n=698 Participants
|
|
Hormone Receptor Status of primary disease
ER-ve PR-ve
|
1 Participants
n=226 Participants
|
0 Participants
n=233 Participants
|
0 Participants
n=239 Participants
|
1 Participants
n=698 Participants
|
|
HER2 Status of primary disease
HER2 +ve
|
14 Participants
n=226 Participants
|
15 Participants
n=233 Participants
|
15 Participants
n=239 Participants
|
44 Participants
n=698 Participants
|
|
HER2 Status of primary disease
HER2 -ve
|
136 Participants
n=226 Participants
|
117 Participants
n=233 Participants
|
134 Participants
n=239 Participants
|
387 Participants
n=698 Participants
|
|
HER2 Status of primary disease
HER2 unknown
|
76 Participants
n=226 Participants
|
101 Participants
n=233 Participants
|
90 Participants
n=239 Participants
|
267 Participants
n=698 Participants
|
|
Time from primary diagnosis to first relapse
|
5.1 years
n=226 Participants
|
5.0 years
n=233 Participants
|
5.2 years
n=239 Participants
|
5.1 years
n=698 Participants
|
PRIMARY outcome
Timeframe: Assessed up to 190 monthsPopulation: Intention to treat (ITT). This population contains all people randomised into the study (regardless of whether they were later found to be ineligible, a protocol deviator, given the wrong treatment allocation, never treated etc.). Comparisons are made by randomised treatment.
defined as time from randomisation to progression of existing disease, new sites of disease, second primary cancer if change in systemic treatment was necessary, or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Faslodex + Placebo
n=226 Participants
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Placebo orally once a day
|
Faslodex + Arimidex
n=233 Participants
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Arimidex (anastrozole) orally once a day
|
Exemestane
n=239 Participants
exemestane orally once a day
Exemestane
|
|---|---|---|---|
|
Progression-free Survival
|
4.8 Months
Interval 3.5 to 5.6
|
4.1 Months
Interval 3.2 to 5.3
|
3.5 Months
Interval 3.0 to 4.9
|
SECONDARY outcome
Timeframe: From start of treatment, every 3 months to treatment discontinuation and/or up to 190 monthsPopulation: ITT
The proportion of patients identified as having a complete response (CR) or partial response (PR) at any time whilst on study treatment. Response is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as either disappearance of all lesions or a \>=30% decrease in the sum of the longest diameter of target lesions with no progressing non-target lesions and no new lesions. Objective Response (OR) = CR + PR
Outcome measures
| Measure |
Faslodex + Placebo
n=226 Participants
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Placebo orally once a day
|
Faslodex + Arimidex
n=233 Participants
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Arimidex (anastrozole) orally once a day
|
Exemestane
n=239 Participants
exemestane orally once a day
Exemestane
|
|---|---|---|---|
|
Objective Response Rate
|
16 Participants
|
17 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Assessed up to 190 monthsPopulation: The number of patients that had an objective response
time from first assessment of response to progression or death. Response is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as either disappearance of all lesions or a \>=30% decrease in the sum of the longest diameter of target lesions with no progressing non-target lesions and no new lesions. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Faslodex + Placebo
n=16 Participants
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Placebo orally once a day
|
Faslodex + Arimidex
n=17 Participants
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Arimidex (anastrozole) orally once a day
|
Exemestane
n=10 Participants
exemestane orally once a day
Exemestane
|
|---|---|---|---|
|
Duration of Response
|
10.2 Months
Interval 2.6 to 18.4
|
8.7 Months
Interval 3.0 to 12.2
|
12.8 Months
Interval 6.2 to 33.4
|
SECONDARY outcome
Timeframe: Assessed up to 190 monthsPopulation: ITT
Complete or partial response or stable disease for at least six months prior to progression. Response is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as either disappearance of all lesions or a \>=30% decrease in the sum of the longest diameter of target lesions with no progressing non-target lesions and no new lesions. Stable disease is neither responding or progressing. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Faslodex + Placebo
n=226 Participants
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Placebo orally once a day
|
Faslodex + Arimidex
n=233 Participants
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Arimidex (anastrozole) orally once a day
|
Exemestane
n=239 Participants
exemestane orally once a day
Exemestane
|
|---|---|---|---|
|
Clinical Benefit Rate
|
55 Participants
|
66 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: Assessed up to 190 monthsPopulation: The number of patients that had clinical benefit, defined as complete or partial response, or stable disease for at least 6 months prior to progression.
Time from first assessment of clinical benefit to progression or death. Response is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as either disappearance of all lesions or a \>=30% decrease in the sum of the longest diameter of target lesions with no progressing non-target lesions and no new lesions. Stable disease is neither responding or progressing. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Clinical benefit = (CR+PR)+(SD\>=6months).
Outcome measures
| Measure |
Faslodex + Placebo
n=55 Participants
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Placebo orally once a day
|
Faslodex + Arimidex
n=66 Participants
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Arimidex (anastrozole) orally once a day
|
Exemestane
n=57 Participants
exemestane orally once a day
Exemestane
|
|---|---|---|---|
|
Duration of Clinical Benefit
|
11.2 months
Interval 8.2 to 16.9
|
11.5 months
Interval 8.0 to 16.3
|
12.2 months
Interval 8.9 to 23.8
|
SECONDARY outcome
Timeframe: To discontinuation of protocol treatment for any reason, or progression of disease assessed up to 190 monthsPopulation: ITT
Time from randomisation to discontinuation of protocol treatment for any reason, or progression of disease
Outcome measures
| Measure |
Faslodex + Placebo
n=226 Participants
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Placebo orally once a day
|
Faslodex + Arimidex
n=233 Participants
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Arimidex (anastrozole) orally once a day
|
Exemestane
n=239 Participants
exemestane orally once a day
Exemestane
|
|---|---|---|---|
|
Time to Treatment Failure
|
3.8 Months
Interval 3.1 to 5.4
|
3.9 Months
Interval 3.0 to 4.7
|
3.4 Months
Interval 3.1 to 4.5
|
SECONDARY outcome
Timeframe: To death assessed up to 190 months.Population: ITT
Time from randomisation until death from any cause.
Outcome measures
| Measure |
Faslodex + Placebo
n=226 Participants
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Placebo orally once a day
|
Faslodex + Arimidex
n=233 Participants
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Arimidex (anastrozole) orally once a day
|
Exemestane
n=239 Participants
exemestane orally once a day
Exemestane
|
|---|---|---|---|
|
Overall Survival
|
20.1 Months
Interval 17.8 to 23.3
|
20.2 Months
Interval 17.0 to 22.6
|
22.5 Months
Interval 20.1 to 24.6
|
SECONDARY outcome
Timeframe: From start of treatment to discontinuation of treatment/progression assessed up to 190 monthsPopulation: Number of patients that received at least one dose of treatment
To evaluate the overall safety and tolerability. The number of patients experiencing at least one adverse event. Refer to adverse event section for more details.
Outcome measures
| Measure |
Faslodex + Placebo
n=225 Participants
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Placebo orally once a day
|
Faslodex + Arimidex
n=231 Participants
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Arimidex (anastrozole) orally once a day
|
Exemestane
n=237 Participants
exemestane orally once a day
Exemestane
|
|---|---|---|---|
|
Tolerability of Treatment
|
221 Participants
|
227 Participants
|
230 Participants
|
Adverse Events
Faslodex + Placebo
Serious events: 31 serious events
Other events: 221 other events
Deaths: 221 deaths
Faslodex + Arimidex
Serious events: 39 serious events
Other events: 227 other events
Deaths: 225 deaths
Exemestane
Serious events: 37 serious events
Other events: 230 other events
Deaths: 227 deaths
Serious adverse events
| Measure |
Faslodex + Placebo
n=225 participants at risk
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Placebo orally once a day
|
Faslodex + Arimidex
n=231 participants at risk
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Arimidex (anastrozole) orally once a day
|
Exemestane
n=237 participants at risk
exemestane orally once a day
Exemestane
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.87%
2/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
General disorders
Swelling
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Blood and lymphatic system disorders
Lymphangitis
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Cardiac disorders
Cardiac operation
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
1.3%
3/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Cardiac disorders
Pericardial effusion
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Eye disorders
Blindness
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Eye disorders
Diplopia
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Gastrointestinal disorders
Abdominal abscess
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Gastrointestinal disorders
Ascites
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Gastrointestinal disorders
Constipation
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.89%
2/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.87%
2/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Gastrointestinal disorders
Dysphagia
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.87%
2/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Gastrointestinal disorders
nausea
|
0.89%
2/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
1.7%
4/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.84%
2/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.84%
2/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
3/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
1.3%
3/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.84%
2/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
General disorders
Chest pain
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
1.3%
3/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
General disorders
Fatigue
|
1.3%
3/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
General disorders
Lethargy
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.87%
2/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
General disorders
Oedema peripheral
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
General disorders
Pain
|
0.89%
2/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
1.3%
3/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
General disorders
Pyrexia
|
0.89%
2/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
1.3%
3/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Infections and infestations
Pneumonia
|
1.3%
3/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
1.3%
3/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Infections and infestations
Sepsis
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.84%
2/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Infections and infestations
Wound infection
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Injury, poisoning and procedural complications
Fall
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Injury, poisoning and procedural complications
Ilium fracture
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Infections and infestations
Tibia fracture
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Investigations
Blood pressure decreased
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Investigations
Body temperature increased
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.87%
2/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Investigations
Platelet count decreased
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
1.3%
3/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.89%
2/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Musculoskeletal and connective tissue disorders
Intramedullary rod insertion
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.87%
2/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma ureter
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Nervous system disorders
Cerebral hemorrhage
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Nervous system disorders
Headache
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.84%
2/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Nervous system disorders
Sedation
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Psychiatric disorders
Confusional state
|
1.3%
3/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.89%
2/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Renal and urinary disorders
Urinary retention
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.84%
2/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
7/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.87%
2/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
1.3%
3/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
1.7%
4/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Surgical and medical procedures
Medical device removal
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Vascular disorders
Deep vein thrombosis
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Vascular disorders
Embolism
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Vascular disorders
Haematemesis
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.43%
1/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Vascular disorders
Hypertension
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.87%
2/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Vascular disorders
Hypotension
|
0.44%
1/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Vascular disorders
Penetrating aortic ulcer
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Vascular disorders
Presyncope
|
0.00%
0/225 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.00%
0/231 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
0.42%
1/237 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
Other adverse events
| Measure |
Faslodex + Placebo
n=225 participants at risk
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Placebo orally once a day
|
Faslodex + Arimidex
n=231 participants at risk
Arimidex/placebo comparator is blinded Faslodex (fulvestrant) IM on day 1,15,29 and monthly thereafter Arimidex (anastrozole) orally once a day
|
Exemestane
n=237 participants at risk
exemestane orally once a day
Exemestane
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.8%
31/225 • Number of events 71 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
10.8%
25/231 • Number of events 59 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
13.5%
32/237 • Number of events 68 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
43.6%
98/225 • Number of events 304 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
42.0%
97/231 • Number of events 314 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
46.4%
110/237 • Number of events 318 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.9%
20/225 • Number of events 37 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
7.4%
17/231 • Number of events 23 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
8.9%
21/237 • Number of events 28 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
5.3%
12/225 • Number of events 18 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
8.2%
19/231 • Number of events 34 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
8.4%
20/237 • Number of events 32 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Gastrointestinal disorders
Constipation
|
25.3%
57/225 • Number of events 124 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
27.7%
64/231 • Number of events 172 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
24.1%
57/237 • Number of events 135 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
8.4%
19/225 • Number of events 39 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
3.0%
7/231 • Number of events 8 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
6.8%
16/237 • Number of events 29 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Metabolism and nutrition disorders
decreased appetite
|
29.8%
67/225 • Number of events 145 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
31.2%
72/231 • Number of events 121 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
28.7%
68/237 • Number of events 127 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Gastrointestinal disorders
diarrhoea
|
23.6%
53/225 • Number of events 105 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
16.9%
39/231 • Number of events 68 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
20.7%
49/237 • Number of events 71 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Nervous system disorders
Dizziness
|
4.4%
10/225 • Number of events 10 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
5.2%
12/231 • Number of events 19 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
6.3%
15/237 • Number of events 17 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Gastrointestinal disorders
Dyspepsia
|
26.2%
59/225 • Number of events 150 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
22.1%
51/231 • Number of events 105 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
29.5%
70/237 • Number of events 122 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.8%
31/225 • Number of events 61 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
6.9%
16/231 • Number of events 23 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
10.5%
25/237 • Number of events 45 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Nervous system disorders
Headache
|
28.9%
65/225 • Number of events 153 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
22.1%
51/231 • Number of events 119 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
21.5%
51/237 • Number of events 114 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Reproductive system and breast disorders
Hot Flush
|
36.0%
81/225 • Number of events 282 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
37.2%
86/231 • Number of events 278 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
33.3%
79/237 • Number of events 215 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Psychiatric disorders
Insomnia
|
28.4%
64/225 • Number of events 192 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
32.9%
76/231 • Number of events 207 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
29.5%
70/237 • Number of events 204 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
General disorders
Lethargy
|
64.4%
145/225 • Number of events 436 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
64.5%
149/231 • Number of events 432 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
56.1%
133/237 • Number of events 386 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Infections and infestations
Lower respiratory tract infection
|
7.1%
16/225 • Number of events 19 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
7.4%
17/231 • Number of events 23 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
5.5%
13/237 • Number of events 14 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Psychiatric disorders
Mood altered
|
26.2%
59/225 • Number of events 157 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
23.8%
55/231 • Number of events 122 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
24.9%
59/237 • Number of events 113 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
General disorders
Mucosal Inflammation
|
10.2%
23/225 • Number of events 57 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
6.5%
15/231 • Number of events 20 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
6.8%
16/237 • Number of events 21 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
General disorders
pain
|
7.1%
16/225 • Number of events 27 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
2.2%
5/231 • Number of events 5 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
4.2%
10/237 • Number of events 16 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.7%
6/225 • Number of events 11 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
6.5%
15/231 • Number of events 29 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
5.9%
14/237 • Number of events 23 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
14/225 • Number of events 17 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
3.5%
8/231 • Number of events 10 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
3.0%
7/237 • Number of events 8 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
|
Gastrointestinal disorders
Vomiting
|
44.9%
101/225 • Number of events 224 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
35.1%
81/231 • Number of events 154 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
38.4%
91/237 • Number of events 147 • Collected from the date each patient commenced treatment. AEs were collected every month for the first six months of the protocol and then every three months until disease progression/treatment discontinuation (assessed up to 190 months).
All events were graded according to CTCAE V3.0. For (S)AEs the analysis population was "as treated", i.e. all patients receiving at least one dose of treatment. For all cause mortality the analysis population is ITT.
|
Additional Information
Professor Judith Bliss (Director of ICR-CTSU)
Institute of Cancer Research, Clinical Trials and Statistics Unit (ICR-CTSU)
Phone: +44 0208 722
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee There is an agreement between principal investigators and the Sponsor (or its agents) that restricts the PIs rights to discuss or publish trial results after the trial is completed.
- Publication restrictions are in place
Restriction type: OTHER