Trial Outcomes & Findings for Sandostatin LAR and Axitinib vs Pbo in Pnts With Advanced Well-differentiated Non-pancreatic Neuroendocrine Carcinomas (NCT NCT01744249)
NCT ID: NCT01744249
Last Updated: 2026-04-28
Results Overview
Calculated from the date of random assignment until the date of first progressive disease or death, whichever occurs first. Progression of the disease was assessed by investigators using tumor imaging computed tomography scans and Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 PFS was analysed by Kaplan-Meier method and compared with log-rank tests. Patients alive with no event at data cut off were censored on their last tumor assessment
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
256 participants
Primary outcome timeframe
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 25 months
Results posted on
2026-04-28
Participant Flow
Patients enrolled and randomized
Participant milestones
| Measure |
Axitinib + Sandostatin LAR
Axitinib 5 mg BID + Sandostatin LAR 30mg/28 days
|
Placebo + Sandostatin LAR
Placebo BID + Sandostatin LAR 30mg/28 days
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
130
|
|
Overall Study
COMPLETED
|
125
|
130
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Axitinib + Sandostatin LAR
Axitinib 5 mg BID + Sandostatin LAR 30mg/28 days
|
Placebo + Sandostatin LAR
Placebo BID + Sandostatin LAR 30mg/28 days
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Axitinib + Sandostatin LAR
n=126 Participants
Axitinib 5 mg BID + Sandostatin LAR 30mg/28 days
|
Placebo + Sandostatin LAR
n=130 Participants
Placebo BID + Sandostatin LAR 30mg/28 days
|
Total
n=256 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=126 Participants
|
60 years
n=130 Participants
|
61 years
n=256 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=126 Participants
|
63 Participants
n=130 Participants
|
118 Participants
n=256 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=126 Participants
|
67 Participants
n=130 Participants
|
138 Participants
n=256 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Eastern Cooperative Oncology Group performance status (ECOG-PS)
Score 0
|
75 Participants
n=126 Participants • yes
|
88 Participants
n=130 Participants • yes
|
163 Participants
n=256 Participants • yes
|
|
Eastern Cooperative Oncology Group performance status (ECOG-PS)
Score 1
|
49 Participants
n=126 Participants • yes
|
41 Participants
n=130 Participants • yes
|
90 Participants
n=256 Participants • yes
|
|
Metastatic sites
Bone · Affected
|
28 Participants
n=126 Participants
|
33 Participants
n=130 Participants
|
61 Participants
n=256 Participants
|
|
Eastern Cooperative Oncology Group performance status (ECOG-PS)
Score 2
|
1 Participants
n=126 Participants • yes
|
0 Participants
n=130 Participants • yes
|
1 Participants
n=256 Participants • yes
|
|
Eastern Cooperative Oncology Group performance status (ECOG-PS)
Unknown
|
1 Participants
n=126 Participants • yes
|
1 Participants
n=130 Participants • yes
|
2 Participants
n=256 Participants • yes
|
|
Tumor grade (WHO)
Grade 1
|
32 Participants
n=126 Participants
|
46 Participants
n=130 Participants
|
78 Participants
n=256 Participants
|
|
Tumor grade (WHO)
Grade 2
|
94 Participants
n=126 Participants
|
83 Participants
n=130 Participants
|
177 Participants
n=256 Participants
|
|
Tumor grade (WHO)
Unknown
|
0 Participants
n=126 Participants
|
1 Participants
n=130 Participants
|
1 Participants
n=256 Participants
|
|
Ki-67
ki-67 0-2
|
31 Participants
n=126 Participants
|
43 Participants
n=130 Participants
|
74 Participants
n=256 Participants
|
|
Metastatic sites
Bone · Not Affected
|
98 Participants
n=126 Participants
|
97 Participants
n=130 Participants
|
195 Participants
n=256 Participants
|
|
Ki-67
ki-67 >2-5
|
45 Participants
n=126 Participants
|
39 Participants
n=130 Participants
|
84 Participants
n=256 Participants
|
|
Ki-67
ki-67 >5 - 10
|
26 Participants
n=126 Participants
|
27 Participants
n=130 Participants
|
53 Participants
n=256 Participants
|
|
Ki-67
ki-67 >10 - 20
|
23 Participants
n=126 Participants
|
19 Participants
n=130 Participants
|
42 Participants
n=256 Participants
|
|
Ki-67
Not specified
|
1 Participants
n=126 Participants
|
2 Participants
n=130 Participants
|
3 Participants
n=256 Participants
|
|
Time from initial cancer diagnosis to study entry
≤ 12 months
|
54 Participants
n=126 Participants
|
51 Participants
n=130 Participants
|
105 Participants
n=256 Participants
|
|
Time from initial cancer diagnosis to study entry
> 12 months
|
72 Participants
n=126 Participants
|
79 Participants
n=130 Participants
|
151 Participants
n=256 Participants
|
|
Primary tumour location
Lung
|
38 Participants
n=126 Participants
|
34 Participants
n=130 Participants
|
72 Participants
n=256 Participants
|
|
Primary tumour location
Gastric
|
3 Participants
n=126 Participants
|
4 Participants
n=130 Participants
|
7 Participants
n=256 Participants
|
|
Primary tumour location
Small intestine
|
60 Participants
n=126 Participants
|
67 Participants
n=130 Participants
|
127 Participants
n=256 Participants
|
|
Primary tumour location
Colorectal
|
13 Participants
n=126 Participants
|
11 Participants
n=130 Participants
|
24 Participants
n=256 Participants
|
|
Primary tumour location
Unknown primary
|
9 Participants
n=126 Participants
|
7 Participants
n=130 Participants
|
16 Participants
n=256 Participants
|
|
Primary tumour location
Other locations
|
3 Participants
n=126 Participants
|
7 Participants
n=130 Participants
|
10 Participants
n=256 Participants
|
|
Number of Organs Affected
1 location
|
41 Participants
n=126 Participants
|
37 Participants
n=130 Participants
|
78 Participants
n=256 Participants
|
|
Number of Organs Affected
2 locations
|
48 Participants
n=126 Participants
|
51 Participants
n=130 Participants
|
99 Participants
n=256 Participants
|
|
Number of Organs Affected
≥3 locations
|
37 Participants
n=126 Participants
|
42 Participants
n=130 Participants
|
79 Participants
n=256 Participants
|
|
Metastatic sites
Liver · Affected
|
111 Participants
n=126 Participants
|
114 Participants
n=130 Participants
|
225 Participants
n=256 Participants
|
|
Metastatic sites
Liver · Not Affected
|
15 Participants
n=126 Participants
|
16 Participants
n=130 Participants
|
31 Participants
n=256 Participants
|
|
Metastatic sites
Lymph nodes · Affected
|
65 Participants
n=126 Participants
|
66 Participants
n=130 Participants
|
131 Participants
n=256 Participants
|
|
Metastatic sites
Lymph nodes · Not Affected
|
61 Participants
n=126 Participants
|
64 Participants
n=130 Participants
|
125 Participants
n=256 Participants
|
|
Metastatic sites
Lung · Affected
|
17 Participants
n=126 Participants
|
21 Participants
n=130 Participants
|
38 Participants
n=256 Participants
|
|
Metastatic sites
Lung · Not Affected
|
109 Participants
n=126 Participants
|
109 Participants
n=130 Participants
|
218 Participants
n=256 Participants
|
|
Carcinoid syndrome
Present
|
35 Participants
n=126 Participants
|
29 Participants
n=130 Participants
|
64 Participants
n=256 Participants
|
|
Carcinoid syndrome
Absent
|
91 Participants
n=126 Participants
|
101 Participants
n=130 Participants
|
192 Participants
n=256 Participants
|
|
Chromogranin A (CGA) levels
≤ upper limit normal (ULN)
|
14 Participants
n=126 Participants
|
23 Participants
n=130 Participants
|
37 Participants
n=256 Participants
|
|
Chromogranin A (CGA) levels
> 1 x ULN
|
14 Participants
n=126 Participants
|
16 Participants
n=130 Participants
|
30 Participants
n=256 Participants
|
|
Chromogranin A (CGA) levels
> 2 x ULN
|
78 Participants
n=126 Participants
|
68 Participants
n=130 Participants
|
146 Participants
n=256 Participants
|
|
Prior systemic treatments
Chemotherapy · Administered
|
18 Participants
n=126 Participants
|
15 Participants
n=130 Participants
|
33 Participants
n=256 Participants
|
|
Chromogranin A (CGA) levels
Not determined
|
20 Participants
n=126 Participants
|
23 Participants
n=130 Participants
|
43 Participants
n=256 Participants
|
|
5-HIAA levels
≤ ULN
|
20 Participants
n=126 Participants
|
25 Participants
n=130 Participants
|
45 Participants
n=256 Participants
|
|
5-HIAA levels
> 1 x ULN
|
14 Participants
n=126 Participants
|
10 Participants
n=130 Participants
|
24 Participants
n=256 Participants
|
|
5-HIAA levels
> 2 x ULN
|
51 Participants
n=126 Participants
|
55 Participants
n=130 Participants
|
106 Participants
n=256 Participants
|
|
5-HIAA levels
Not determined
|
41 Participants
n=126 Participants
|
40 Participants
n=130 Participants
|
81 Participants
n=256 Participants
|
|
Lactate dehydrogenase (LDH) levels
≤ ULN
|
86 Participants
n=126 Participants
|
94 Participants
n=130 Participants
|
180 Participants
n=256 Participants
|
|
Lactate dehydrogenase (LDH) levels
> 1 x ULN
|
27 Participants
n=126 Participants
|
24 Participants
n=130 Participants
|
51 Participants
n=256 Participants
|
|
Lactate dehydrogenase (LDH) levels
Not determined
|
13 Participants
n=126 Participants
|
12 Participants
n=130 Participants
|
25 Participants
n=256 Participants
|
|
Number of prior lines of systemic treatment
0 line
|
54 Participants
n=126 Participants
|
61 Participants
n=130 Participants
|
115 Participants
n=256 Participants
|
|
Number of prior lines of systemic treatment
1 line
|
43 Participants
n=126 Participants
|
41 Participants
n=130 Participants
|
84 Participants
n=256 Participants
|
|
Number of prior lines of systemic treatment
≥2
|
29 Participants
n=126 Participants
|
28 Participants
n=130 Participants
|
57 Participants
n=256 Participants
|
|
Prior systemic treatments
Somatostatin analogs (SSA) · Administered
|
58 Participants
n=126 Participants
|
57 Participants
n=130 Participants
|
115 Participants
n=256 Participants
|
|
Prior systemic treatments
Somatostatin analogs (SSA) · NOT administered
|
68 Participants
n=126 Participants
|
73 Participants
n=130 Participants
|
141 Participants
n=256 Participants
|
|
Prior systemic treatments
Everolimus · Administered
|
17 Participants
n=126 Participants
|
14 Participants
n=130 Participants
|
31 Participants
n=256 Participants
|
|
Prior systemic treatments
Everolimus · NOT administered
|
109 Participants
n=126 Participants
|
116 Participants
n=130 Participants
|
225 Participants
n=256 Participants
|
|
Prior systemic treatments
Chemotherapy · NOT administered
|
108 Participants
n=126 Participants
|
115 Participants
n=130 Participants
|
223 Participants
n=256 Participants
|
|
Prior systemic treatments
Radioligand therapy (RLT) · Administered
|
8 Participants
n=126 Participants
|
4 Participants
n=130 Participants
|
12 Participants
n=256 Participants
|
|
Prior systemic treatments
Radioligand therapy (RLT) · NOT administered
|
118 Participants
n=126 Participants
|
126 Participants
n=130 Participants
|
244 Participants
n=256 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 25 monthsCalculated from the date of random assignment until the date of first progressive disease or death, whichever occurs first. Progression of the disease was assessed by investigators using tumor imaging computed tomography scans and Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 PFS was analysed by Kaplan-Meier method and compared with log-rank tests. Patients alive with no event at data cut off were censored on their last tumor assessment
Outcome measures
| Measure |
Axitinib + Sandostatin LAR
n=126 Participants
Axitinib 5 mg BID + Sandostatin LAR 30mg/28 days
|
Placebo + Sandostatin LAR
n=130 Participants
Placebo BID + Sandostatin LAR 30mg/28 days
|
|---|---|---|
|
Efficacy of Axitinib in Terms of PFS (Investigator Assessment)
|
17.2 months
Interval 13.6 to 24.7
|
13.1 months
Interval 10.9 to 18.6
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 25 monthsMeasured changes in the sum of longest diameter of target lesions measured in mm according to RECIST 1.1 criteria. Assessed by investigators. Patients are categorized depending on the percentage of tumor redution: Complete response (CR): dissapearance of all lesions Partial response (PR): reduction \> 30% in the sum of longest diameter of target lesions Stable disease (SD): Tumor size betwee 30% reduction and 20% increase in the sum of longest diameter of target lesions Progressive disease (PD): increase \> 20% in the sum of longest diameter of target lesions ORR comprise all patients who achieved at least a CR or PR at any timepoint during follow-up.
Outcome measures
| Measure |
Axitinib + Sandostatin LAR
n=126 Participants
Axitinib 5 mg BID + Sandostatin LAR 30mg/28 days
|
Placebo + Sandostatin LAR
n=130 Participants
Placebo BID + Sandostatin LAR 30mg/28 days
|
|---|---|---|
|
Objective Response Rate (ORR) (Investigator Assessment)
Partial response
|
20 Participants
|
5 Participants
|
|
Objective Response Rate (ORR) (Investigator Assessment)
Complete response
|
2 Participants
|
1 Participants
|
|
Objective Response Rate (ORR) (Investigator Assessment)
Stable disease
|
87 Participants
|
96 Participants
|
|
Objective Response Rate (ORR) (Investigator Assessment)
Progressive disease
|
9 Participants
|
25 Participants
|
|
Objective Response Rate (ORR) (Investigator Assessment)
Not evaluable
|
8 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 25 monthsPopulation: Only analyzed in patients with baseline elevation of CgA or 5-HIAA levels, respectively
measurable in mL/ 24h and ng/ml respectively, through blood and urine test in patients with baseline elevation of CgA or 5-HIAA levels. This endpoint measures the negativization of these two tumor biomarkers.
Outcome measures
| Measure |
Axitinib + Sandostatin LAR
n=69 Participants
Axitinib 5 mg BID + Sandostatin LAR 30mg/28 days
|
Placebo + Sandostatin LAR
n=72 Participants
Placebo BID + Sandostatin LAR 30mg/28 days
|
|---|---|---|
|
Biochemical Response (5-OH-indoleacetic Acid and Chromogranin A)
CgA response · Response
|
31 Participants
|
27 Participants
|
|
Biochemical Response (5-OH-indoleacetic Acid and Chromogranin A)
CgA response · No response
|
38 Participants
|
45 Participants
|
|
Biochemical Response (5-OH-indoleacetic Acid and Chromogranin A)
5-HIAA response · Response
|
19 Participants
|
16 Participants
|
|
Biochemical Response (5-OH-indoleacetic Acid and Chromogranin A)
5-HIAA response · No response
|
29 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 25 monthsPopulation: One patient in axitinib group withdrew consent to participate before receiving any dose of study treatment. Therefore this patient was not included for the assessment of safety as defined in protocol (safety population)
All adverse events and serious adverse events will be monitored with regular monitoring of hematology and blood chemistry parameters and regular physical examinations. Adverse events will be evaluated continuously throughout the study. Safety and tolerability will be assessed according to the National Institute of Health/National Cancer Institute (NIH/NCI) Common Terminology Criteria for Adverse Events version 4 (CTCAE v4)
Outcome measures
| Measure |
Axitinib + Sandostatin LAR
n=125 Participants
Axitinib 5 mg BID + Sandostatin LAR 30mg/28 days
|
Placebo + Sandostatin LAR
n=130 Participants
Placebo BID + Sandostatin LAR 30mg/28 days
|
|---|---|---|
|
Safety and Tolerability of Axitinib (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE], Version 4.0)
Toxicities requiring dose reductions · No, no events reported
|
81 Participants
|
120 Participants
|
|
Safety and Tolerability of Axitinib (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE], Version 4.0)
Any grade AEs · Yes, reported events
|
121 Participants
|
124 Participants
|
|
Safety and Tolerability of Axitinib (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE], Version 4.0)
Any grade AEs · No, no events reported
|
4 Participants
|
6 Participants
|
|
Safety and Tolerability of Axitinib (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE], Version 4.0)
SAEs · Yes, reported events
|
48 Participants
|
30 Participants
|
|
Safety and Tolerability of Axitinib (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE], Version 4.0)
SAEs · No, no events reported
|
77 Participants
|
100 Participants
|
|
Safety and Tolerability of Axitinib (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE], Version 4.0)
Toxicities requiring end of treatment · Yes, reported events
|
23 Participants
|
4 Participants
|
|
Safety and Tolerability of Axitinib (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE], Version 4.0)
Toxicities requiring end of treatment · No, no events reported
|
102 Participants
|
126 Participants
|
|
Safety and Tolerability of Axitinib (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE], Version 4.0)
Toxicities requiring treatment temporary interruption · Yes, reported events
|
76 Participants
|
55 Participants
|
|
Safety and Tolerability of Axitinib (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE], Version 4.0)
Toxicities requiring treatment temporary interruption · No, no events reported
|
49 Participants
|
75 Participants
|
|
Safety and Tolerability of Axitinib (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE], Version 4.0)
Toxicities requiring dose reductions · Yes, reported events
|
44 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 25 monthsCalculated from the date of random assignment until the date of first progressive disease or death, whichever occurs first. Progression of the disease was assessed by central blinded reviewers using tumor imaging by computed tomography scans and Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 PFS was analysed by Kaplan-Meier method and compared with log-rank tests. Patients alive with no event at data cut off were censored on their last tumor assessment
Outcome measures
| Measure |
Axitinib + Sandostatin LAR
n=126 Participants
Axitinib 5 mg BID + Sandostatin LAR 30mg/28 days
|
Placebo + Sandostatin LAR
n=130 Participants
Placebo BID + Sandostatin LAR 30mg/28 days
|
|---|---|---|
|
Efficacy of Axitinib in Terms of PFS (Central Blinded Assessment)
|
16.6 months
Interval 13.5 to 24.2
|
9.9 months
Interval 8.2 to 13.9
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 25 monthsPopulation: Nine patients in the axitinib arm and four in the placebo arm were not evaluable for response (lack of tumor assessments).
Measured changes in the sum of longest diameter of target lesions measured in mm according to RECIST 1.1 criteria. Assessed by central blinded reviewers. Patients are categorized depending on the percentage of tumor redution: Complete response (CR): dissapearance of all lesions Partial response (PR): reduction \> 30% in the sum of longest diameter of target lesions Stable disease (SD): Tumor size betwee 30% reduction and 20% increase in the sum of longest diameter of target lesions Progressive disease (PD): increase \> 20% in the sum of longest diameter of target lesions ORR comprise all patients who achieved at least a CR or PR at any timepoint during follow-up.
Outcome measures
| Measure |
Axitinib + Sandostatin LAR
n=117 Participants
Axitinib 5 mg BID + Sandostatin LAR 30mg/28 days
|
Placebo + Sandostatin LAR
n=126 Participants
Placebo BID + Sandostatin LAR 30mg/28 days
|
|---|---|---|
|
Objective Response Rate (ORR) (Central Blinded Assessment)
Partial response
|
13 Participants
|
4 Participants
|
|
Objective Response Rate (ORR) (Central Blinded Assessment)
Not evaluable
|
3 Participants
|
1 Participants
|
|
Objective Response Rate (ORR) (Central Blinded Assessment)
Complete response
|
2 Participants
|
0 Participants
|
|
Objective Response Rate (ORR) (Central Blinded Assessment)
Stable disease
|
98 Participants
|
109 Participants
|
|
Objective Response Rate (ORR) (Central Blinded Assessment)
Progressive disease
|
1 Participants
|
12 Participants
|
Adverse Events
Axitinib + Sandostatin LAR
Serious events: 48 serious events
Other events: 121 other events
Deaths: 68 deaths
Placebo + Sandostatin LAR
Serious events: 30 serious events
Other events: 124 other events
Deaths: 48 deaths
Serious adverse events
| Measure |
Axitinib + Sandostatin LAR
n=125 participants at risk
Axitinib 5 mg BID + Sandostatin LAR 30mg/28 days
|
Placebo + Sandostatin LAR
n=130 participants at risk
Placebo BID + Sandostatin LAR 30mg/28 days
|
|---|---|---|
|
Product Issues
Overdose
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Cardiac disorders
Angina pectoris
|
1.6%
2/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.4%
3/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
1.5%
2/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Infections and infestations
Bacteraemia
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Cardiac disorders
Arteriospasm coronary
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Vascular disorders
Hypertensive crisis
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
3/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.4%
3/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
2.3%
3/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Metabolism and nutrition disorders
Carcinoid syndrome
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Vascular disorders
Hypertension
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
1.5%
2/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
1.5%
2/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Nervous system disorders
Cognitive disorder
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Cardiac disorders
Chest pain
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
General disorders
Cancer pain
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Nervous system disorders
Seizure
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Infections and infestations
COVID-19
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
2.3%
3/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Cardiac disorders
Acute coronary syndrome
|
1.6%
2/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Cardiac disorders
Atrial fibrillation
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Nervous system disorders
Encephalopathy
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Cardiac disorders
Cardiac failure
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
General disorders
Asthenia
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
1.5%
2/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Infections and infestations
Anorectal infection
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Nervous system disorders
Paraesthesia
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Vascular disorders
Haematoma
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Hepatobiliary disorders
Cholangitis
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Hepatobiliary disorders
Liver abscess
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Infections and infestations
Sepsis
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Infections and infestations
Influenza
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Gastrointestinal disorders
Subileus
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
General disorders
Pyrexia
|
1.6%
2/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Hepatobiliary disorders
Hepatic encephalopathy
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Cardiac disorders
Ischaemic stroke
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Gastrointestinal disorders
Constipation
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Vascular disorders
Pulmonary valve stenosis
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
General disorders
General physical health deterioration
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.6%
2/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Number of events 2 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma metastatic
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Nervous system disorders
Confusional state
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Infections and infestations
Pneumonia
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Renal and urinary disorders
Prerenal failure
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Musculoskeletal and connective tissue disorders
Thoracic vertebral fracture
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.6%
2/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
General disorders
Malaise
|
0.80%
1/125 • Number of events 2 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Gastrointestinal disorders
Ascites
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Musculoskeletal and connective tissue disorders
Joint dislocation
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Infections and infestations
Septic shock
|
0.80%
1/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Gastrointestinal disorders
Vomiting
|
0.80%
1/125 • Number of events 2 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Gastrointestinal disorders
Dysphagia
|
0.80%
1/125 • Number of events 2 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
Other adverse events
| Measure |
Axitinib + Sandostatin LAR
n=125 participants at risk
Axitinib 5 mg BID + Sandostatin LAR 30mg/28 days
|
Placebo + Sandostatin LAR
n=130 participants at risk
Placebo BID + Sandostatin LAR 30mg/28 days
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
7.2%
9/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
3.8%
5/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Gastrointestinal disorders
Flatulence
|
7.2%
9/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
8.5%
11/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Investigations
Aspartate aminotransferase increased
|
6.4%
8/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
2.3%
3/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.8%
6/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
6.2%
8/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Gastrointestinal disorders
Constipation
|
4.0%
5/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
7.7%
10/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Gastrointestinal disorders
Diarrhea
|
64.8%
81/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
40.0%
52/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Vascular disorders
Hypertension
|
52.8%
66/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
34.6%
45/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
General disorders
Asthenia
|
52.8%
66/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
34.6%
45/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Gastrointestinal disorders
Mucosal inflammation
|
29.6%
37/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
13.1%
17/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.4%
33/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
12.3%
16/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
20.0%
25/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
3.1%
4/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Gastrointestinal disorders
Nausea
|
14.4%
18/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
13.1%
17/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Nervous system disorders
Headache
|
14.4%
18/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
11.5%
15/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Nervous system disorders
Aphonia
|
15.2%
19/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Nervous system disorders
Dysphonia
|
15.2%
19/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.77%
1/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.2%
14/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
10.8%
14/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Endocrine disorders
Hypothyroidism
|
12.0%
15/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
1.5%
2/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.2%
14/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
5.4%
7/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Metabolism and nutrition disorders
Weight decreased
|
11.2%
14/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
0.00%
0/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
General disorders
Fatigue
|
8.8%
11/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
9.2%
12/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
10/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
5.4%
7/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.0%
10/125 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
8.5%
11/130 • Throughout study period, approximately 5 years
Most frequent treatment-related adverse events (Safety dataset). Cutoff threshold of 5% incidence of event in any subgroup.
|
Additional Information
Secretary
Grupo Español de Tumores Neuroendocrinos y Endocrinos (GETNE)
Phone: 0034934344412
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place