Trial Outcomes & Findings for Osimertinib and Bevacizumab Versus Osimertinib Alone as Second-line Treatment in Stage IIIb-IVb NSCLC With Confirmed EGFRm and T790M (NCT NCT03133546)
NCT ID: NCT03133546
Last Updated: 2026-02-06
Results Overview
PFS is defined as the time from the date of randomisation until documented progression (based on RECIST 1.1 criteria) or death, if progression is not documented. Censoring (for patients without progression/death) will occur at the last tumour assessment if patient is lost to follow-up or refuses further documentation of follow-up.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
155 participants
Primary outcome timeframe
Evaluated up to approximately 45 months from the randomisation of the first patient.
Results posted on
2026-02-06
Participant Flow
Participant milestones
| Measure |
Osimertinib Plus Bevacizumab
Patients will receive treatment with osimertinib and bevacizumab until disease progression, lack of tolerability or the patient declines further treatment. Treatment may also continue beyond progression for as long as the patient may still derive benefit.
Osimertinib: Osimertinib is administered orally at 80mg once daily. Doses should be taken approximately 24 hours apart at the same time point each day. The appropriate number of osimertinib tablets will be provided to patients to be self-administered at home. AstraZeneca will supply osimertinib as tablets for oral administration.
AstraZeneca will supply osimertinib as tablets for oral administration.
Bevacizumab: Bevacizumab is administered at 15mg/kg intravenously on day 1 of every 3-week cycle. Bevacizumab for intravenous administration will be supplied by Roche.
|
Osimertinib Alone
Patients will receive treatment with osimertinib until disease progression, lack of tolerability or the patient declines further treatment. Treatment may also continue beyond progression for as long as the patient may still derive benefit.
Osimertinib: Osimertinib is administered orally at 80mg once daily. Doses should be taken approximately 24 hours apart at the same time point each day. The appropriate number of osimertinib tablets will be provided to patients to be self-administered at home. AstraZeneca will supply osimertinib as tablets for oral administration.
AstraZeneca will supply osimertinib as tablets for oral administration.
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
77
|
|
Overall Study
Received at least one dose of trial treatment
|
76
|
77
|
|
Overall Study
On treatment
|
1
|
8
|
|
Overall Study
Treatment failures
|
75
|
69
|
|
Overall Study
Never started treatment
|
2
|
0
|
|
Overall Study
COMPLETED
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
51
|
50
|
Reasons for withdrawal
| Measure |
Osimertinib Plus Bevacizumab
Patients will receive treatment with osimertinib and bevacizumab until disease progression, lack of tolerability or the patient declines further treatment. Treatment may also continue beyond progression for as long as the patient may still derive benefit.
Osimertinib: Osimertinib is administered orally at 80mg once daily. Doses should be taken approximately 24 hours apart at the same time point each day. The appropriate number of osimertinib tablets will be provided to patients to be self-administered at home. AstraZeneca will supply osimertinib as tablets for oral administration.
AstraZeneca will supply osimertinib as tablets for oral administration.
Bevacizumab: Bevacizumab is administered at 15mg/kg intravenously on day 1 of every 3-week cycle. Bevacizumab for intravenous administration will be supplied by Roche.
|
Osimertinib Alone
Patients will receive treatment with osimertinib until disease progression, lack of tolerability or the patient declines further treatment. Treatment may also continue beyond progression for as long as the patient may still derive benefit.
Osimertinib: Osimertinib is administered orally at 80mg once daily. Doses should be taken approximately 24 hours apart at the same time point each day. The appropriate number of osimertinib tablets will be provided to patients to be self-administered at home. AstraZeneca will supply osimertinib as tablets for oral administration.
AstraZeneca will supply osimertinib as tablets for oral administration.
|
|---|---|---|
|
Overall Study
Death
|
46
|
43
|
|
Overall Study
Withdrawal/Lost to follow-up
|
5
|
7
|
Baseline Characteristics
Osimertinib and Bevacizumab Versus Osimertinib Alone as Second-line Treatment in Stage IIIb-IVb NSCLC With Confirmed EGFRm and T790M
Baseline characteristics by cohort
| Measure |
Osimertinib Plus Bevacizumab
n=78 Participants
Patients will receive treatment with osimertinib and bevacizumab until disease progression, lack of tolerability or the patient declines further treatment. Treatment may also continue beyond progression for as long as the patient may still derive benefit.
Osimertinib: Osimertinib is administered orally at 80mg once daily. Doses should be taken approximately 24 hours apart at the same time point each day. The appropriate number of osimertinib tablets will be provided to patients to be self-administered at home. AstraZeneca will supply osimertinib as tablets for oral administration.
AstraZeneca will supply osimertinib as tablets for oral administration.
Bevacizumab: Bevacizumab is administered at 15mg/kg intravenously on day 1 of every 3-week cycle. Bevacizumab for intravenous administration will be supplied by Roche.
|
Osimertinib Alone
n=77 Participants
Patients will receive treatment with osimertinib until disease progression, lack of tolerability or the patient declines further treatment. Treatment may also continue beyond progression for as long as the patient may still derive benefit.
Osimertinib: Osimertinib is administered orally at 80mg once daily. Doses should be taken approximately 24 hours apart at the same time point each day. The appropriate number of osimertinib tablets will be provided to patients to be self-administered at home. AstraZeneca will supply osimertinib as tablets for oral administration.
AstraZeneca will supply osimertinib as tablets for oral administration.
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=41 Participants
|
66 years
n=1581 Participants
|
67 years
n=4626 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=41 Participants
|
49 Participants
n=1581 Participants
|
96 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=41 Participants
|
28 Participants
n=1581 Participants
|
59 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Asian
|
32 Participants
n=41 Participants
|
31 Participants
n=1581 Participants
|
63 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Non-Asian
|
46 Participants
n=41 Participants
|
46 Participants
n=1581 Participants
|
92 Participants
n=4626 Participants
|
|
ECOG Performance Status
0
|
22 Participants
n=41 Participants
|
25 Participants
n=1581 Participants
|
47 Participants
n=4626 Participants
|
|
ECOG Performance Status
1
|
51 Participants
n=41 Participants
|
48 Participants
n=1581 Participants
|
99 Participants
n=4626 Participants
|
|
ECOG Performance Status
2
|
5 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
9 Participants
n=4626 Participants
|
|
Smoking status
Current smoker
|
4 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
|
Smoking status
Former smoker
|
30 Participants
n=41 Participants
|
27 Participants
n=1581 Participants
|
57 Participants
n=4626 Participants
|
|
Smoking status
Never smoked
|
44 Participants
n=41 Participants
|
49 Participants
n=1581 Participants
|
93 Participants
n=4626 Participants
|
|
Stage
IIIB/C
|
2 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Stage
IVA/B
|
76 Participants
n=41 Participants
|
76 Participants
n=1581 Participants
|
152 Participants
n=4626 Participants
|
|
Stage
Missing
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Use of prior platinum-based chemotherapy
|
11 Participants
n=41 Participants
|
13 Participants
n=1581 Participants
|
24 Participants
n=4626 Participants
|
|
Prior EGFR TKI
Erlotinib/gefitinib
|
57 Participants
n=41 Participants
|
57 Participants
n=1581 Participants
|
114 Participants
n=4626 Participants
|
|
Prior EGFR TKI
Afatinib/dacomitinib
|
21 Participants
n=41 Participants
|
19 Participants
n=1581 Participants
|
40 Participants
n=4626 Participants
|
|
Prior EGFR TKI
Other
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
EGFR mutation type
Exon 19 deletion
|
58 Participants
n=41 Participants
|
51 Participants
n=1581 Participants
|
109 Participants
n=4626 Participants
|
|
EGFR mutation type
Exon 21 L858R
|
20 Participants
n=41 Participants
|
26 Participants
n=1581 Participants
|
46 Participants
n=4626 Participants
|
|
T790M testing material
ctDNA
|
38 Participants
n=41 Participants
|
37 Participants
n=1581 Participants
|
75 Participants
n=4626 Participants
|
|
T790M testing material
Tumour
|
40 Participants
n=41 Participants
|
40 Participants
n=1581 Participants
|
80 Participants
n=4626 Participants
|
|
Brain metastasis
Yes
|
13 Participants
n=41 Participants
|
8 Participants
n=1581 Participants
|
21 Participants
n=4626 Participants
|
|
Brain metastasis
No
|
65 Participants
n=41 Participants
|
69 Participants
n=1581 Participants
|
134 Participants
n=4626 Participants
|
|
Liver metastasis
Yes
|
14 Participants
n=41 Participants
|
8 Participants
n=1581 Participants
|
22 Participants
n=4626 Participants
|
|
Liver metastasis
No
|
64 Participants
n=41 Participants
|
69 Participants
n=1581 Participants
|
133 Participants
n=4626 Participants
|
|
Pleural effusion and ascites
Yes
|
7 Participants
n=41 Participants
|
9 Participants
n=1581 Participants
|
16 Participants
n=4626 Participants
|
|
Pleural effusion and ascites
No
|
71 Participants
n=41 Participants
|
68 Participants
n=1581 Participants
|
139 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: Evaluated up to approximately 45 months from the randomisation of the first patient.Population: Efficacy population (Intention-To-Treat cohort of all randomised patients)
PFS is defined as the time from the date of randomisation until documented progression (based on RECIST 1.1 criteria) or death, if progression is not documented. Censoring (for patients without progression/death) will occur at the last tumour assessment if patient is lost to follow-up or refuses further documentation of follow-up.
Outcome measures
| Measure |
Osimertinib Plus Bevacizumab
n=78 Participants
Patients will receive treatment with osimertinib and bevacizumab until disease progression, lack of tolerability or the patient declines further treatment. Treatment may also continue beyond progression for as long as the patient may still derive benefit.
Osimertinib: Osimertinib is administered orally at 80mg once daily. Doses should be taken approximately 24 hours apart at the same time point each day. The appropriate number of osimertinib tablets will be provided to patients to be self-administered at home. AstraZeneca will supply osimertinib as tablets for oral administration.
AstraZeneca will supply osimertinib as tablets for oral administration.
Bevacizumab: Bevacizumab is administered at 15mg/kg intravenously on day 1 of every 3-week cycle. Bevacizumab for intravenous administration will be supplied by Roche.
|
Osimertinib Alone
n=77 Participants
Patients will receive treatment with osimertinib until disease progression, lack of tolerability or the patient declines further treatment. Treatment may also continue beyond progression for as long as the patient may still derive benefit.
Osimertinib: Osimertinib is administered orally at 80mg once daily. Doses should be taken approximately 24 hours apart at the same time point each day. The appropriate number of osimertinib tablets will be provided to patients to be self-administered at home. AstraZeneca will supply osimertinib as tablets for oral administration.
AstraZeneca will supply osimertinib as tablets for oral administration.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
15.4 months
Interval 9.2 to 18.0
|
12.3 months
Interval 6.2 to 17.2
|
SECONDARY outcome
Timeframe: Evaluated up to approximately 45 months from the randomisation of the first patient.Population: Efficacy population (Intention-To-Treat cohort of all randomised patients)
ORR is defined as the percentage of patients reaching a complete or partial response, across all assessment time-points according to RECIST criteria v1.1, during the period from randomisation to termination of trial treatment.
Outcome measures
| Measure |
Osimertinib Plus Bevacizumab
n=78 Participants
Patients will receive treatment with osimertinib and bevacizumab until disease progression, lack of tolerability or the patient declines further treatment. Treatment may also continue beyond progression for as long as the patient may still derive benefit.
Osimertinib: Osimertinib is administered orally at 80mg once daily. Doses should be taken approximately 24 hours apart at the same time point each day. The appropriate number of osimertinib tablets will be provided to patients to be self-administered at home. AstraZeneca will supply osimertinib as tablets for oral administration.
AstraZeneca will supply osimertinib as tablets for oral administration.
Bevacizumab: Bevacizumab is administered at 15mg/kg intravenously on day 1 of every 3-week cycle. Bevacizumab for intravenous administration will be supplied by Roche.
|
Osimertinib Alone
n=77 Participants
Patients will receive treatment with osimertinib until disease progression, lack of tolerability or the patient declines further treatment. Treatment may also continue beyond progression for as long as the patient may still derive benefit.
Osimertinib: Osimertinib is administered orally at 80mg once daily. Doses should be taken approximately 24 hours apart at the same time point each day. The appropriate number of osimertinib tablets will be provided to patients to be self-administered at home. AstraZeneca will supply osimertinib as tablets for oral administration.
AstraZeneca will supply osimertinib as tablets for oral administration.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
43 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: Evaluated up to approximately 45 months from the randomisation of the first patient.Population: Efficacy population (Intention-To-Treat cohort of all randomised patients)
DCR is defined as the percentage of patients reaching a complete or partial response, or disease stabilisation confirmed at subsequent radiological assessment, across all assessment time-points according to RECIST criteria v1.1, during the period from randomisation to termination of trial treatment.
Outcome measures
| Measure |
Osimertinib Plus Bevacizumab
n=78 Participants
Patients will receive treatment with osimertinib and bevacizumab until disease progression, lack of tolerability or the patient declines further treatment. Treatment may also continue beyond progression for as long as the patient may still derive benefit.
Osimertinib: Osimertinib is administered orally at 80mg once daily. Doses should be taken approximately 24 hours apart at the same time point each day. The appropriate number of osimertinib tablets will be provided to patients to be self-administered at home. AstraZeneca will supply osimertinib as tablets for oral administration.
AstraZeneca will supply osimertinib as tablets for oral administration.
Bevacizumab: Bevacizumab is administered at 15mg/kg intravenously on day 1 of every 3-week cycle. Bevacizumab for intravenous administration will be supplied by Roche.
|
Osimertinib Alone
n=77 Participants
Patients will receive treatment with osimertinib until disease progression, lack of tolerability or the patient declines further treatment. Treatment may also continue beyond progression for as long as the patient may still derive benefit.
Osimertinib: Osimertinib is administered orally at 80mg once daily. Doses should be taken approximately 24 hours apart at the same time point each day. The appropriate number of osimertinib tablets will be provided to patients to be self-administered at home. AstraZeneca will supply osimertinib as tablets for oral administration.
AstraZeneca will supply osimertinib as tablets for oral administration.
|
|---|---|---|
|
Disease Control Rate (DCR)
|
70 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: Evaluated up to approximately 45 months from the randomisation of the first patient.Population: Safety population (all patients who received at least 1 dose of trial treatment).
Adverse events, graded by CTCAE version 4.0, will be recorded from date of signature of informed consent until 30 days after all trial treatment discontinuation.
Outcome measures
| Measure |
Osimertinib Plus Bevacizumab
n=76 Participants
Patients will receive treatment with osimertinib and bevacizumab until disease progression, lack of tolerability or the patient declines further treatment. Treatment may also continue beyond progression for as long as the patient may still derive benefit.
Osimertinib: Osimertinib is administered orally at 80mg once daily. Doses should be taken approximately 24 hours apart at the same time point each day. The appropriate number of osimertinib tablets will be provided to patients to be self-administered at home. AstraZeneca will supply osimertinib as tablets for oral administration.
AstraZeneca will supply osimertinib as tablets for oral administration.
Bevacizumab: Bevacizumab is administered at 15mg/kg intravenously on day 1 of every 3-week cycle. Bevacizumab for intravenous administration will be supplied by Roche.
|
Osimertinib Alone
n=77 Participants
Patients will receive treatment with osimertinib until disease progression, lack of tolerability or the patient declines further treatment. Treatment may also continue beyond progression for as long as the patient may still derive benefit.
Osimertinib: Osimertinib is administered orally at 80mg once daily. Doses should be taken approximately 24 hours apart at the same time point each day. The appropriate number of osimertinib tablets will be provided to patients to be self-administered at home. AstraZeneca will supply osimertinib as tablets for oral administration.
AstraZeneca will supply osimertinib as tablets for oral administration.
|
|---|---|---|
|
Adverse Events
Experienced AE/SAE
|
76 Participants
|
76 Participants
|
|
Adverse Events
No AE/SAE
|
0 Participants
|
1 Participants
|
|
Adverse Events
Experienced SAE
|
33 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Evaluated up to approximately 45 months from the randomisation of the first patient.Population: Efficacy population (Intention-To-Treat cohort of all randomised patients)
OS is defined as time from the date of randomisation until death from any cause. Censoring will occur at the last follow-up date.
Outcome measures
| Measure |
Osimertinib Plus Bevacizumab
n=78 Participants
Patients will receive treatment with osimertinib and bevacizumab until disease progression, lack of tolerability or the patient declines further treatment. Treatment may also continue beyond progression for as long as the patient may still derive benefit.
Osimertinib: Osimertinib is administered orally at 80mg once daily. Doses should be taken approximately 24 hours apart at the same time point each day. The appropriate number of osimertinib tablets will be provided to patients to be self-administered at home. AstraZeneca will supply osimertinib as tablets for oral administration.
AstraZeneca will supply osimertinib as tablets for oral administration.
Bevacizumab: Bevacizumab is administered at 15mg/kg intravenously on day 1 of every 3-week cycle. Bevacizumab for intravenous administration will be supplied by Roche.
|
Osimertinib Alone
n=77 Participants
Patients will receive treatment with osimertinib until disease progression, lack of tolerability or the patient declines further treatment. Treatment may also continue beyond progression for as long as the patient may still derive benefit.
Osimertinib: Osimertinib is administered orally at 80mg once daily. Doses should be taken approximately 24 hours apart at the same time point each day. The appropriate number of osimertinib tablets will be provided to patients to be self-administered at home. AstraZeneca will supply osimertinib as tablets for oral administration.
AstraZeneca will supply osimertinib as tablets for oral administration.
|
|---|---|---|
|
Overall Survival (OS)
|
24.0 months
Interval 17.8 to 32.1
|
24.3 months
Interval 16.9 to 37.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Available for translational research, following completion of the primary trial research objectives.Population: Patients with available NGS plasma sample.
Tumour tissue blocks, plasma and serum samples will be collected at trial entry and at disease progression on trial treatment.
Outcome measures
| Measure |
Osimertinib Plus Bevacizumab
n=76 Participants
Patients will receive treatment with osimertinib and bevacizumab until disease progression, lack of tolerability or the patient declines further treatment. Treatment may also continue beyond progression for as long as the patient may still derive benefit.
Osimertinib: Osimertinib is administered orally at 80mg once daily. Doses should be taken approximately 24 hours apart at the same time point each day. The appropriate number of osimertinib tablets will be provided to patients to be self-administered at home. AstraZeneca will supply osimertinib as tablets for oral administration.
AstraZeneca will supply osimertinib as tablets for oral administration.
Bevacizumab: Bevacizumab is administered at 15mg/kg intravenously on day 1 of every 3-week cycle. Bevacizumab for intravenous administration will be supplied by Roche.
|
Osimertinib Alone
n=73 Participants
Patients will receive treatment with osimertinib until disease progression, lack of tolerability or the patient declines further treatment. Treatment may also continue beyond progression for as long as the patient may still derive benefit.
Osimertinib: Osimertinib is administered orally at 80mg once daily. Doses should be taken approximately 24 hours apart at the same time point each day. The appropriate number of osimertinib tablets will be provided to patients to be self-administered at home. AstraZeneca will supply osimertinib as tablets for oral administration.
AstraZeneca will supply osimertinib as tablets for oral administration.
|
|---|---|---|
|
T790M Evolution in Tissue and Plasma/Serum Between Baseline and Disease Progression (PD) on Trial Treatment.
T790M base to PD: Not applicable (No PD)
|
22 Participants
|
18 Participants
|
|
T790M Evolution in Tissue and Plasma/Serum Between Baseline and Disease Progression (PD) on Trial Treatment.
T790M base to PD: No clearance
|
8 Participants
|
8 Participants
|
|
T790M Evolution in Tissue and Plasma/Serum Between Baseline and Disease Progression (PD) on Trial Treatment.
T790M base to PD: Clearance
|
18 Participants
|
13 Participants
|
|
T790M Evolution in Tissue and Plasma/Serum Between Baseline and Disease Progression (PD) on Trial Treatment.
T790M base to PD: Mutation at PD only
|
0 Participants
|
1 Participants
|
|
T790M Evolution in Tissue and Plasma/Serum Between Baseline and Disease Progression (PD) on Trial Treatment.
T790M base to PD: No mutation
|
6 Participants
|
8 Participants
|
|
T790M Evolution in Tissue and Plasma/Serum Between Baseline and Disease Progression (PD) on Trial Treatment.
T790M base to PD: Missing
|
22 Participants
|
25 Participants
|
Adverse Events
Osimertinib Plus Bevacizumab
Serious events: 33 serious events
Other events: 76 other events
Deaths: 46 deaths
Osimertinib Alone
Serious events: 27 serious events
Other events: 76 other events
Deaths: 43 deaths
Serious adverse events
| Measure |
Osimertinib Plus Bevacizumab
n=76 participants at risk
Patients will receive treatment with osimertinib and bevacizumab until disease progression, lack of tolerability or the patient declines further treatment. Treatment may also continue beyond progression for as long as the patient may still derive benefit.
Osimertinib: Osimertinib is administered orally at 80mg once daily. Doses should be taken approximately 24 hours apart at the same time point each day. The appropriate number of osimertinib tablets will be provided to patients to be self-administered at home. AstraZeneca will supply osimertinib as tablets for oral administration.
AstraZeneca will supply osimertinib as tablets for oral administration.
Bevacizumab: Bevacizumab is administered at 15mg/kg intravenously on day 1 of every 3-week cycle. Bevacizumab for intravenous administration will be supplied by Roche.
|
Osimertinib Alone
n=77 participants at risk
Patients will receive treatment with osimertinib until disease progression, lack of tolerability or the patient declines further treatment. Treatment may also continue beyond progression for as long as the patient may still derive benefit.
Osimertinib: Osimertinib is administered orally at 80mg once daily. Doses should be taken approximately 24 hours apart at the same time point each day. The appropriate number of osimertinib tablets will be provided to patients to be self-administered at home. AstraZeneca will supply osimertinib as tablets for oral administration.
AstraZeneca will supply osimertinib as tablets for oral administration.
|
|---|---|---|
|
Vascular disorders
Thromboembolic event
|
2.6%
2/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
3.9%
3/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
1.3%
1/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Psychiatric disorders
Mania
|
0.00%
0/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
1.3%
1/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Cardiac disorders
Heart failure
|
2.6%
2/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Cardiac disorders
Atrial fibrillation
|
3.9%
3/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
1.3%
1/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Surgical and medical procedures
Pleurodesis of malignant pleural effusion
|
0.00%
0/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
1.3%
1/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
1.3%
1/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
1.3%
1/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
1.3%
1/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric carcinoma
|
0.00%
0/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
1.3%
1/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Diarrhea
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
1.3%
1/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Mucositis oral
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
3.9%
3/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
2.6%
2/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Colitis
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Gastric perforation
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Investigations
Lipase increased
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
1.3%
1/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
1.3%
1/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
1.3%
1/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
0.00%
0/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
1.3%
1/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Splenic infection
|
0.00%
0/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
1.3%
1/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
General disorders
Fever
|
0.00%
0/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
2.6%
2/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
General disorders
Drug overdose
|
3.9%
3/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
2.6%
2/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Infections and infestations
Upper respiratory infection
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
2.6%
2/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Infections and infestations
Urinary tract infection
|
2.6%
2/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Infections and infestations
Lung infection
|
5.3%
4/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
2.6%
2/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
1.3%
1/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Infections and infestations
Bronchial infection
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Infections and infestations
COVID-19 infection
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Infections and infestations
Enterocolitis infectious
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Infections and infestations
Hepatitis caused by COVID-19 infection
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Infections and infestations
Influenza
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Infections and infestations
Influenza A
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
1.3%
1/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Infections and infestations
Pleural infection
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Infections and infestations
Sepsis
|
0.00%
0/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
1.3%
1/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
1.3%
1/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Nervous system disorders
Seizure
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
1.3%
1/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Nervous system disorders
Depressed level of consciousness
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Nervous system disorders
Stroke
|
0.00%
0/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
1.3%
1/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
1.3%
1/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Vascular disorders
Hypertension
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
0.00%
0/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
Other adverse events
| Measure |
Osimertinib Plus Bevacizumab
n=76 participants at risk
Patients will receive treatment with osimertinib and bevacizumab until disease progression, lack of tolerability or the patient declines further treatment. Treatment may also continue beyond progression for as long as the patient may still derive benefit.
Osimertinib: Osimertinib is administered orally at 80mg once daily. Doses should be taken approximately 24 hours apart at the same time point each day. The appropriate number of osimertinib tablets will be provided to patients to be self-administered at home. AstraZeneca will supply osimertinib as tablets for oral administration.
AstraZeneca will supply osimertinib as tablets for oral administration.
Bevacizumab: Bevacizumab is administered at 15mg/kg intravenously on day 1 of every 3-week cycle. Bevacizumab for intravenous administration will be supplied by Roche.
|
Osimertinib Alone
n=77 participants at risk
Patients will receive treatment with osimertinib until disease progression, lack of tolerability or the patient declines further treatment. Treatment may also continue beyond progression for as long as the patient may still derive benefit.
Osimertinib: Osimertinib is administered orally at 80mg once daily. Doses should be taken approximately 24 hours apart at the same time point each day. The appropriate number of osimertinib tablets will be provided to patients to be self-administered at home. AstraZeneca will supply osimertinib as tablets for oral administration.
AstraZeneca will supply osimertinib as tablets for oral administration.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
53.9%
41/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
49.4%
38/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
19/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
20.8%
16/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Mucositis oral
|
25.0%
19/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
13.0%
10/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Nausea
|
22.4%
17/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
16.9%
13/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Vomiting
|
22.4%
17/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
9.1%
7/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.2%
7/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
5.2%
4/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Dry mouth
|
2.6%
2/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
10.4%
8/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Investigations
Lipase increased
|
15.8%
12/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
16.9%
13/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Investigations
Serum amylase increased
|
15.8%
12/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
16.9%
13/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Investigations
Platelet count decreased
|
19.7%
15/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
11.7%
9/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Investigations
Neutrophil count decreased
|
9.2%
7/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
13.0%
10/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Investigations
Alanine aminotransferase increased
|
13.2%
10/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
7.8%
6/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Investigations
Aspartate aminotransferase increased
|
13.2%
10/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
6.5%
5/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
13.2%
10/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
6.5%
5/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Investigations
Ejection fraction decreased
|
11.8%
9/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
1.3%
1/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Investigations
Alkaline phosphatase increased
|
7.9%
6/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
3.9%
3/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Investigations
Creatinine increased
|
9.2%
7/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
2.6%
2/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Investigations
White blood cell decreased
|
6.6%
5/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
5.2%
4/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Investigations
GGT increased
|
7.9%
6/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
2.6%
2/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.8%
31/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
36.4%
28/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.1%
13/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
22.1%
17/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
21.1%
16/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
5.2%
4/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
9.2%
7/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
3.9%
3/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.9%
3/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
6.5%
5/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
35.5%
27/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
24.7%
19/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
21.1%
16/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
19.5%
15/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.5%
8/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
19.5%
15/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.9%
6/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
6.5%
5/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Infections and infestations
Upper respiratory infection
|
21.1%
16/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
19.5%
15/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Infections and infestations
Paronychia
|
17.1%
13/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
16.9%
13/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Infections and infestations
Urinary tract infection
|
7.9%
6/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
7.8%
6/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.2%
10/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
14.3%
11/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.9%
3/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
11.7%
9/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
4/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
6.5%
5/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.6%
5/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
3.9%
3/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Nervous system disorders
Headache
|
23.7%
18/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
11.7%
9/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Nervous system disorders
Dizziness
|
11.8%
9/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
14.3%
11/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Metabolism and nutrition disorders
Anorexia
|
31.6%
24/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
22.1%
17/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.9%
6/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
5.2%
4/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.9%
3/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
7.8%
6/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Vascular disorders
Hypertension
|
42.1%
32/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
9.1%
7/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Renal and urinary disorders
Proteinuria
|
48.7%
37/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
2.6%
2/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Eye disorders
Dry eye
|
5.3%
4/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
13.0%
10/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Eye disorders
Blurred vision
|
5.3%
4/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
6.5%
5/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Psychiatric disorders
Anxiety
|
1.3%
1/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
9.1%
7/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
Blood and lymphatic system disorders
Anemia
|
9.2%
7/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
15.6%
12/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
General disorders
Fatigue
|
43.4%
33/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
37.7%
29/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
General disorders
Pain
|
28.9%
22/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
15.6%
12/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
General disorders
Fever
|
7.9%
6/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
13.0%
10/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
General disorders
Edema limbs
|
13.2%
10/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
5.2%
4/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
General disorders
Non-cardiac chest pain
|
11.8%
9/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
1.3%
1/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
|
General disorders
Flu like symptoms
|
7.9%
6/76 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
3.9%
3/77 • Continuously from date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 45 months from the randomisation of the first patient.
Adverse event (AE) is defined as any untoward medical occurrence that occurs from the date of signature of informed consent until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 4.0.
|
Additional Information
Dr. Heidi Roschitzki, PhD
ETOP IBCSG Partners Foundation
Phone: +41 31 511 94 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place