Trial Outcomes & Findings for Savolitinib vs. Sunitinib in MET-driven PRCC. (NCT NCT03091192)
NCT ID: NCT03091192
Last Updated: 2026-01-23
Results Overview
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): \>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of randomisation until the date of PD (defined by Recist 1.1 and confirmed by BICR) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
60 participants
Primary outcome timeframe
RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.
Results posted on
2026-01-23
Participant Flow
First subject enrolled: 25 July 2017. Last subject last visit: 18 August 2019. Data cut off: 19 August 2019. The study was terminated prematurely. Randomized subjects continue to receive IMP as clinically indicated by PI; safety information is being collected for those subjects.
Participant milestones
| Measure |
Savolitinib QD
Savolitinib QD
|
Sunitinib QD
Sunitinib QD
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
27
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
33
|
27
|
Reasons for withdrawal
| Measure |
Savolitinib QD
Savolitinib QD
|
Sunitinib QD
Sunitinib QD
|
|---|---|---|
|
Overall Study
Study terminated by sponsor
|
21
|
14
|
|
Overall Study
Death
|
9
|
13
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Savolitinib vs. Sunitinib in MET-driven PRCC.
Baseline characteristics by cohort
| Measure |
Savolitinib QD
n=33 Participants
Savolitinib QD
|
Sunitinib QD
n=27 Participants
Sunitinib QD
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.7 Years
STANDARD_DEVIATION 13.81 • n=270 Participants
|
63.1 Years
STANDARD_DEVIATION 9.60 • n=4 Participants
|
59.6 Years
STANDARD_DEVIATION 12.43 • n=9 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=270 Participants
|
10 Participants
n=4 Participants
|
14 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=270 Participants
|
17 Participants
n=4 Participants
|
46 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=270 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=270 Participants
|
23 Participants
n=4 Participants
|
52 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.Population: Full Analysis Set (All randomised patients)
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): \>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of randomisation until the date of PD (defined by Recist 1.1 and confirmed by BICR) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression.
Outcome measures
| Measure |
Savolitinib QD
n=17 Events
Savolitinib QD
|
Sunitinib QD
n=20 Events
Sunitinib QD
|
|---|---|---|
|
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)
|
7.0 Months
Interval 2.8 to
The upper limit was not calculable.
|
5.6 Months
Interval 4.1 to 6.9
|
SECONDARY outcome
Timeframe: RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.Population: Full Analysis Set (All randomised patients)
Time between the date of randomisation and the date of death due to any cause.
Outcome measures
| Measure |
Savolitinib QD
n=33 Participants
Savolitinib QD
|
Sunitinib QD
n=27 Participants
Sunitinib QD
|
|---|---|---|
|
Overall Survival (OS)
Died
|
9 Participants
|
13 Participants
|
|
Overall Survival (OS)
Terminated study prior to death
|
24 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.Population: Full Analysis Set (All randomised patients)
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR prior to progression or any further therapy.
Outcome measures
| Measure |
Savolitinib QD
n=33 Participants
Savolitinib QD
|
Sunitinib QD
n=27 Participants
Sunitinib QD
|
|---|---|---|
|
Objective Response Rate (ORR) by BICR
|
27.3 % of participants
Interval 13.3 to 45.5
|
7.4 % of participants
Interval 0.9 to 24.3
|
SECONDARY outcome
Timeframe: RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.Population: Duration of Response (DoR) by BICR was calculated for all responders (N=11)
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR is the time from the date of first documented response until the date of documented progression or death in the absence of disease progression.
Outcome measures
| Measure |
Savolitinib QD
n=9 Participants
Savolitinib QD
|
Sunitinib QD
n=2 Participants
Sunitinib QD
|
|---|---|---|
|
Duration of Response (DoR) by BICR
|
NA Months
There were no patients (0/9) with an objective response who subsequently had PFS events. There were 2 subjects that are known to have died but are censored for PFS as death occurred \> 14 weeks after last evaluable RECIST assessment.
|
8.3 Months
The confidence limits were not calculable. There was 1 patient with an objective response who subsequently progressed or died in the sunitinib group.
|
SECONDARY outcome
Timeframe: RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.Population: Full Analysis Set (All randomised patients)
Disease control rate at 6 months is defined as the percentage of patients who have a best objective response of Complete Response or Partial Response in that period or who have demonstrated Stable Disease for a minimum interval of 23 weeks.
Outcome measures
| Measure |
Savolitinib QD
n=33 Participants
Savolitinib QD
|
Sunitinib QD
n=27 Participants
Sunitinib QD
|
|---|---|---|
|
Disease Control Rate (DCR) at 6 Months by BICR
|
48.5 % of participants
Interval 30.8 to 66.5
|
37.0 % of participants
Interval 19.4 to 57.6
|
SECONDARY outcome
Timeframe: RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.Population: Full Analysis Set (All randomised patients)
Disease control rate at 12 months is defined as the percentage of patients who have a best objective response of complete responses or partial responses in that period or who have demonstrated stable disease for a minimum interval of 47 weeks.
Outcome measures
| Measure |
Savolitinib QD
n=33 Participants
Savolitinib QD
|
Sunitinib QD
n=27 Participants
Sunitinib QD
|
|---|---|---|
|
Disease Control Rate (DCR) at 12 Months by BICR
|
30.3 % of participants
Interval 15.6 to 48.7
|
22.2 % of participants
Interval 8.6 to 42.3
|
Adverse Events
Savolitinib QD
Serious events: 8 serious events
Other events: 25 other events
Deaths: 9 deaths
Sunitinib QD
Serious events: 8 serious events
Other events: 27 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Savolitinib QD
n=33 participants at risk
Savolitinib QD
|
Sunitinib QD
n=27 participants at risk
Sunitinib QD
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
3.7%
1/27 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
3.7%
1/27 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Immune system disorders
Drug hypersensitivity
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/27 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/27 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
3.7%
1/27 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
3.7%
1/27 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
3.7%
1/27 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Cardiac disorders
Ventricular tachycardia
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/27 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
3.7%
1/27 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Vascular disorders
Thrombophlebitis
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/27 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/27 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/27 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
3.7%
1/27 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
3.7%
1/27 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Ascites
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/27 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/27 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/27 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Hepatobiliary disorders
Biliary dilatation
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/27 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Hepatobiliary disorders
Cholangitis
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/27 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Hepatobiliary disorders
Jaundice
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/27 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
General disorders
Condition aggravated
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
3.7%
1/27 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
General disorders
Oedema peripheral
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/27 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Alanine aminotransferase increased
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/27 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Aspartate aminotransferase increased
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/27 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
Other adverse events
| Measure |
Savolitinib QD
n=33 participants at risk
Savolitinib QD
|
Sunitinib QD
n=27 participants at risk
Sunitinib QD
|
|---|---|---|
|
Infections and infestations
Conjuntivitis
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
7.4%
2/27 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
14.8%
4/27 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.1%
2/33 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
44.4%
12/27 • Number of events 18 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
7.4%
2/27 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
18.5%
5/27 • Number of events 11 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
22.2%
6/27 • Number of events 8 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
29.6%
8/27 • Number of events 10 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
7.4%
2/27 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.1%
2/33 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/27 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
9.1%
3/33 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
7.4%
2/27 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
7.4%
2/27 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Nervous system disorders
Headache
|
9.1%
3/33 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
14.8%
4/27 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
7.4%
2/27 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Cardiac disorders
Tachycardia
|
6.1%
2/33 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
3.7%
1/27 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Vascular disorders
Capillary leak syndrome
|
9.1%
3/33 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/27 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Vascular disorders
Hypertension
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
22.2%
6/27 • Number of events 9 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.1%
4/33 • Number of events 5 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
22.2%
6/27 • Number of events 6 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
21.2%
7/33 • Number of events 7 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
14.8%
4/27 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
14.8%
4/27 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Constipation
|
6.1%
2/33 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
7.4%
2/27 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
22.2%
6/27 • Number of events 19 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.0%
1/33 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
11.1%
3/27 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Nausea
|
6.1%
2/33 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
33.3%
9/27 • Number of events 13 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
7.4%
2/27 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Stomatitis
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
7.4%
2/27 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
14.8%
4/27 • Number of events 6 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
25.9%
7/27 • Number of events 7 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Amylase increased
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
7.4%
2/27 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
7.4%
2/27 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.1%
2/33 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
3.7%
1/27 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Skin and subcutaneous tissue disorders
Yellow skin
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
14.8%
4/27 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
7.4%
2/27 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
2/33 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
7.4%
2/27 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
18.5%
5/27 • Number of events 5 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
7.4%
2/27 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.1%
2/33 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
11.1%
3/27 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Renal and urinary disorders
Chronic kidney disease
|
6.1%
2/33 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
3.7%
1/27 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Renal and urinary disorders
Proteinuria
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
7.4%
2/27 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
General disorders
Asthenia
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
18.5%
5/27 • Number of events 5 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
General disorders
Face oedema
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
11.1%
3/27 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
General disorders
Fatigue
|
6.1%
2/33 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
18.5%
5/27 • Number of events 5 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
11.1%
3/27 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
General disorders
Oedema peripheral
|
33.3%
11/33 • Number of events 17 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
11.1%
3/27 • Number of events 4 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
General disorders
Peripheral swelling
|
6.1%
2/33 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
0.00%
0/27 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
General disorders
Pyrexia
|
6.1%
2/33 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
7.4%
2/27 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Alanine aminotransferase increased
|
21.2%
7/33 • Number of events 11 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
11.1%
3/27 • Number of events 5 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Aspartate aminotransferase increased
|
21.2%
7/33 • Number of events 9 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
18.5%
5/27 • Number of events 7 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Blood creatinine increased
|
27.3%
9/33 • Number of events 10 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
7.4%
2/27 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
11.1%
3/27 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
14.8%
4/27 • Number of events 7 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Body temperature increased
|
9.1%
3/33 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
7.4%
2/27 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
11.1%
3/27 • Number of events 3 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Lipase increased
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
7.4%
2/27 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
18.5%
5/27 • Number of events 11 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Platelet count decreased
|
3.0%
1/33 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
14.8%
4/27 • Number of events 5 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Thyroxine increased
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
7.4%
2/27 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
Weight decreased
|
0.00%
0/33 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
7.4%
2/27 • Number of events 2 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
|
Investigations
White blood cell count decreased
|
3.0%
1/33 • Number of events 1 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
|
11.1%
3/27 • Number of events 5 • Adverse Events (AEs) and Serious Adverse Events (SAEs) were collected throughout the study, from date of informed consent until 30 days after the last dose of study treatment.
Systematic assessment due to regular investigator assessment at study visits.
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Additional Information
Global Clinical Lead
AstraZeneca Clinical Study Information Center
Phone: 1-877-240-9479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place