Trial Outcomes & Findings for A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib (NCT NCT03673501)
NCT ID: NCT03673501
Last Updated: 2026-02-05
Results Overview
PFS is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review using modified RECIST Version 1.1-(mRECIST 1.1) GIST specific, or death due to any cause. Per mRECIST 1.1, progression was defined using mRECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
453 participants
Primary outcome timeframe
From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years)
Results posted on
2026-02-05
Participant Flow
Participant milestones
| Measure |
Ripretinib
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
|
Sunitinib
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
|
|---|---|---|
|
Overall Study
STARTED
|
226
|
227
|
|
Overall Study
COMPLETED
|
190
|
203
|
|
Overall Study
NOT COMPLETED
|
36
|
24
|
Reasons for withdrawal
| Measure |
Ripretinib
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
|
Sunitinib
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
|
|---|---|---|
|
Overall Study
Participants ongoing.
|
36
|
24
|
Baseline Characteristics
A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib
Baseline characteristics by cohort
| Measure |
Ripretinib
n=226 Participants
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
|
Sunitinib
n=227 Participants
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
|
Total
n=453 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-64 years
|
145 Participants
n=25 Participants
|
143 Participants
n=26 Participants
|
288 Participants
n=51 Participants
|
|
Age, Customized
65-74 years
|
56 Participants
n=25 Participants
|
66 Participants
n=26 Participants
|
122 Participants
n=51 Participants
|
|
Age, Customized
75 years and older
|
25 Participants
n=25 Participants
|
18 Participants
n=26 Participants
|
43 Participants
n=51 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=25 Participants
|
85 Participants
n=26 Participants
|
172 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=25 Participants
|
142 Participants
n=26 Participants
|
281 Participants
n=51 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
14 Participants
n=25 Participants
|
14 Participants
n=26 Participants
|
28 Participants
n=51 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
1 Participants
n=26 Participants
|
1 Participants
n=51 Participants
|
|
Race/Ethnicity, Customized
Asian
|
31 Participants
n=25 Participants
|
27 Participants
n=26 Participants
|
58 Participants
n=51 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=25 Participants
|
1 Participants
n=26 Participants
|
3 Participants
n=51 Participants
|
|
Race/Ethnicity, Customized
White
|
148 Participants
n=25 Participants
|
152 Participants
n=26 Participants
|
300 Participants
n=51 Participants
|
|
Race/Ethnicity, Customized
Not Report
|
30 Participants
n=25 Participants
|
30 Participants
n=26 Participants
|
60 Participants
n=51 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=25 Participants
|
2 Participants
n=26 Participants
|
3 Participants
n=51 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Score at Screening
ECOG Score 0
|
131 Participants
n=25 Participants
|
128 Participants
n=26 Participants
|
259 Participants
n=51 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Score at Screening
ECOG Score 1
|
92 Participants
n=25 Participants
|
98 Participants
n=26 Participants
|
190 Participants
n=51 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Score at Screening
ECOG Score 2
|
3 Participants
n=25 Participants
|
1 Participants
n=26 Participants
|
4 Participants
n=51 Participants
|
|
Mutation Type per Electronic Data Capture (EDC)
KIT Exon 9
|
31 Participants
n=25 Participants
|
28 Participants
n=26 Participants
|
59 Participants
n=51 Participants
|
|
Mutation Type per Electronic Data Capture (EDC)
KIT Exon 11
|
167 Participants
n=25 Participants
|
169 Participants
n=26 Participants
|
336 Participants
n=51 Participants
|
|
Mutation Type per Electronic Data Capture (EDC)
KIT/PDGFRA WT
|
14 Participants
n=25 Participants
|
16 Participants
n=26 Participants
|
30 Participants
n=51 Participants
|
|
Mutation Type per Electronic Data Capture (EDC)
Other KIT (absence of Exon 9 or 11)/PDGFRA
|
14 Participants
n=25 Participants
|
14 Participants
n=26 Participants
|
28 Participants
n=51 Participants
|
|
Intolerance to Imatinib per Electronic Data Capture (EDC)
Yes
|
15 Participants
n=25 Participants
|
19 Participants
n=26 Participants
|
34 Participants
n=51 Participants
|
|
Intolerance to Imatinib per Electronic Data Capture (EDC)
No
|
211 Participants
n=25 Participants
|
208 Participants
n=26 Participants
|
419 Participants
n=51 Participants
|
|
Mutation Type per Interactive Response Technology (IRT)
KIT Exon 9
|
31 Participants
n=25 Participants
|
29 Participants
n=26 Participants
|
60 Participants
n=51 Participants
|
|
Mutation Type per Interactive Response Technology (IRT)
KIT Exon 11
|
163 Participants
n=25 Participants
|
164 Participants
n=26 Participants
|
327 Participants
n=51 Participants
|
|
Mutation Type per Interactive Response Technology (IRT)
KIT/PDGFRA wild type (WT)
|
15 Participants
n=25 Participants
|
18 Participants
n=26 Participants
|
33 Participants
n=51 Participants
|
|
Mutation Type per Interactive Response Technology (IRT)
Other KIT (absence of Exon 9 or 11)/PDGFRA
|
17 Participants
n=25 Participants
|
16 Participants
n=26 Participants
|
33 Participants
n=51 Participants
|
|
Intolerance to Imatinib per Interactive Response Technology (IRT)
Yes
|
22 Participants
n=25 Participants
|
23 Participants
n=26 Participants
|
45 Participants
n=51 Participants
|
|
Intolerance to Imatinib per Interactive Response Technology (IRT)
No
|
204 Participants
n=25 Participants
|
204 Participants
n=26 Participants
|
408 Participants
n=51 Participants
|
PRIMARY outcome
Timeframe: From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years)Population: The KIT Exon 11 Intent to Treat (ITT) Population is defined as all patients who are designated as having a mutation in KIT Exon 11 at the time of randomization. Patients in this population will be analyzed according to the treatment they were scheduled to receive.
PFS is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review using modified RECIST Version 1.1-(mRECIST 1.1) GIST specific, or death due to any cause. Per mRECIST 1.1, progression was defined using mRECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Ripretinib
n=163 Participants
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
|
Sunitinib
n=164 Participants
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
|
|---|---|---|
|
Progression Free Survival (PFS) in the KIT Exon 11 Intent to Treat (ITT) Population
|
8.3 months
Interval 6.8 to 13.3
|
7.0 months
Interval 5.6 to 10.9
|
PRIMARY outcome
Timeframe: From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years)Population: All patient (AP) Intent to Treat (ITT) Population is defined as all patients who are randomized. Patients in this population will be analyzed according to the treatment they were scheduled to receive.
PFS is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review using modified RECIST Version 1.1-(mRECIST 1.1) Gastrointestinal stromal tumor (GIST) specific, or death due to any cause. Per mRECIST 1.1, progression was defined using mRECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Ripretinib
n=226 Participants
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
|
Sunitinib
n=227 Participants
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
|
|---|---|---|
|
Progression Free Survival (PFS) in the All Patient (AP) Intent to Treat (ITT) Population
|
8.0 months
Interval 6.5 to 10.8
|
8.3 months
Interval 6.3 to 11.0
|
SECONDARY outcome
Timeframe: From confirmed CR or PR to disease progression (up to 1.74 years)Population: The KIT Exon 11 Intent to Treat (ITT) Population is defined as all patients who are designated as having a mutation in KIT Exon 11 at the time of randomization. Patients in this population will be analyzed according to the treatment they were scheduled to receive.
ORR was defined as the proportion of patients with confirmed complete response (CR) + confirmed partial response (PR) based on independent radiologic review using modified RECIST (mRECIST) criteria as best overall response. Per mRECIST 1.1 criteria, complete response is defined as disappearance of all target lesions; partial response is defined as \>=30% decrease in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Ripretinib
n=163 Participants
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
|
Sunitinib
n=164 Participants
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
|
|---|---|---|
|
Objective Response Rate (ORR) in the KIT Exon 11 Intent to Treat (ITT) Population Population
|
23.9 percentage of participants
Interval 17.6 to 31.2
|
14.6 percentage of participants
Interval 9.6 to 21.0
|
SECONDARY outcome
Timeframe: From confirmed CR or PR to disease progression (up to 1.74 years)Population: All patient (AP) Intent to Treat (ITT) Population is defined as all patients who are randomized. Patients in this population will be analyzed according to the treatment they were scheduled to receive.
ORR was defined as the proportion of patients with confirmed complete response (CR) + confirmed partial response (PR) based on independent radiologic review using modified RECIST (mRECIST) criteria as best overall response. Per mRECIST 1.1 criteria, complete response is defined as disappearance of all target lesions; partial response is defined as \>=30% decrease in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Ripretinib
n=226 Participants
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
|
Sunitinib
n=227 Participants
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
|
|---|---|---|
|
Objective Response Rate (ORR) in the All Patient (AP) Intent to Treat (ITT) Population
|
21.7 percentage of participants
Interval 16.5 to 27.6
|
17.6 percentage of participants
Interval 12.9 to 23.2
|
SECONDARY outcome
Timeframe: From date of randomization until death due to any cause (up to 3.33 years)Population: The KIT Exon 11 Intent to Treat (ITT) Population is defined as all patients who are designated as having a mutation in KIT Exon 11 at the time of randomization. Patients in this population will be analyzed according to the treatment they were scheduled to receive.
OS was defined as the time from the date of randomization until death due to any cause.
Outcome measures
| Measure |
Ripretinib
n=163 Participants
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
|
Sunitinib
n=164 Participants
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
|
|---|---|---|
|
Overall Survival (OS) in the KIT Exon 11 Intent to Treat (ITT) Population
|
34.0 months
Interval 29.3 to
Upper limit of 95% confidence interval (CI) was not estimable due to fewer number of participants with events
|
31.5 months
Interval 29.4 to
Upper limit of 95% confidence interval (CI) was not estimable due to fewer number of participants with events
|
SECONDARY outcome
Timeframe: From date of randomization until death due to any cause (up to 3.33 years)Population: All patient (AP) Intent to Treat (ITT) Population is defined as all patients who are randomized. Patients in this population will be analyzed according to the treatment they were scheduled to receive.
OS was defined as the time from the date of randomization until death due to any cause.
Outcome measures
| Measure |
Ripretinib
n=226 Participants
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
|
Sunitinib
n=227 Participants
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
|
|---|---|---|
|
Overall Survival (OS) in the All Patient (AP) Intent to Treat (ITT) Population
|
35.5 months
Interval 29.3 to
Upper limit of 95% confidence interval (CI) was not estimable due to fewer number of participants with events
|
30.9 months
Interval 28.9 to
Upper limit of 95% confidence interval (CI) was not estimable due to fewer number of participants with events
|
Adverse Events
Ripretinib
Serious events: 64 serious events
Other events: 221 other events
Deaths: 90 deaths
Sunitinib
Serious events: 61 serious events
Other events: 219 other events
Deaths: 95 deaths
Serious adverse events
| Measure |
Ripretinib
n=223 participants at risk
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
|
Sunitinib
n=221 participants at risk
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.90%
2/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
4/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.90%
2/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
3/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
6/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
2.7%
6/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.90%
2/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.90%
2/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.90%
2/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.90%
2/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Faecaloma
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.90%
2/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
General disorders
General physical health deterioration
|
2.2%
5/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
General disorders
Localised oedema
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
General disorders
Malaise
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.90%
2/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Infections and infestations
COVID-19
|
2.2%
5/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.90%
2/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.90%
2/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.90%
2/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
1.4%
3/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Infections and infestations
Abdominal abscess
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Infections and infestations
Abdominal infection
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Infections and infestations
Anorectal infection
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Infections and infestations
Pelvic abscess
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Infections and infestations
Perirectal abscess
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.90%
2/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Infections and infestations
Vestibular neuronitis
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Infections and infestations
Escherichia peritonitis
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Infections and infestations
Infection
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.90%
2/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.90%
2/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.90%
2/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acral lentiginous melanoma
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.90%
2/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour rupture
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Nervous system disorders
Encephalopathy
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.90%
2/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Psychiatric disorders
Psychomotor retardation
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.90%
2/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.90%
2/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.90%
2/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.90%
2/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Vascular disorders
Hypertensive crisis
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.90%
2/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Vascular disorders
Hypertensive urgency
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure acute
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Cardiac disorders
Supraventricular extrasustoles
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
General disorders
Disease progression
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
General disorders
Sudden death
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Acquired encephalocele
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Nervous system disorders
Seizure
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.45%
1/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
Other adverse events
| Measure |
Ripretinib
n=223 participants at risk
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
|
Sunitinib
n=221 participants at risk
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
7.6%
17/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
7.2%
16/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
8.1%
18/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
36.7%
81/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.8%
13/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
10.4%
23/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.1%
7/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
15.8%
35/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
2.7%
6/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
5.9%
13/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Oral pain
|
1.3%
3/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
5.9%
13/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
General disorders
Fatigue
|
37.7%
84/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
41.2%
91/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
General disorders
Asthenia
|
17.0%
38/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
18.6%
41/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
8.5%
19/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
9.5%
21/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
General disorders
Pyrexia
|
6.3%
14/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
9.0%
20/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Investigations
Weight decreased
|
17.9%
40/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
13.1%
29/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
9.0%
20/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
7.2%
16/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Investigations
Lipase increased
|
8.5%
19/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
9.0%
20/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
15/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
10.9%
24/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
5.8%
13/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
6.8%
15/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
0.90%
2/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
19.0%
42/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.90%
2/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
14.5%
32/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Investigations
White blood cell count decreased
|
0.45%
1/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
10.0%
22/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.9%
60/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
24.4%
54/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.6%
8/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
5.0%
11/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.7%
6/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
5.4%
12/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.8%
4/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
5.0%
11/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
36.3%
81/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
11.3%
25/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
26.5%
59/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
6.8%
15/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.0%
38/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
16.3%
36/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
23/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
7.2%
16/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.3%
14/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
7.2%
16/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
11.7%
26/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
1.4%
3/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
10.3%
23/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
2.7%
6/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
5.4%
12/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
5.4%
12/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
6.7%
15/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
8.1%
18/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
3.6%
8/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
14.9%
33/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
8.5%
19/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
5.9%
13/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
6.3%
14/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
4.1%
9/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.1%
27/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
8.1%
18/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.3%
23/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
5.4%
12/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
8.1%
18/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
1.8%
4/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.2%
5/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
6.8%
15/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
64.6%
144/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
8.1%
18/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
27.4%
61/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
52.5%
116/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
22.0%
49/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
7.2%
16/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.8%
33/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
15.4%
34/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.6%
28/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
8.1%
18/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
8.1%
18/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
2.3%
5/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.6%
17/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
6.3%
14/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
6.7%
15/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
2.3%
5/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
2.2%
5/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
5.0%
11/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
26.9%
60/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
48.0%
106/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
5.4%
12/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
0.00%
0/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
3.1%
7/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
5.0%
11/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
16.1%
36/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
17.6%
39/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.4%
12/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
4.1%
9/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
11.2%
25/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
14.0%
31/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.90%
2/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
6.3%
14/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
12.7%
28/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
35.4%
79/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
21.7%
48/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.6%
57/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
15.8%
35/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
24.2%
54/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
25.3%
56/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.1%
47/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
48.4%
107/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
12.1%
27/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
14.0%
31/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.5%
19/223 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
17.2%
38/221 • Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place