Trial Outcomes & Findings for A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC) (NCT NCT02627963)
NCT ID: NCT02627963
Last Updated: 2023-07-18
Results Overview
The PFS, as assessed by a blinded independent radiological review (IRR), is defined as the time from randomization to first documentation of objective tumor progression (progressive disease) or death due to any reasons whichever comes first. Disease progression per RECIST 1.1 criteria is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
350 participants
Primary outcome timeframe
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Disease progression was assessed every 8 weeks (up to approximately 5 years)
Results posted on
2023-07-18
Participant Flow
A total of 350 participants were randomised and 343 were treated.
Participant milestones
| Measure |
Tivozanib Hydrochloride
Participants randomized to this arm received the study drug, tivozanib hydrochloride.
|
Sorafenib
Participants randomized to this arm received the comparator drug, sorafenib.
|
|---|---|---|
|
Overall Study
STARTED
|
175
|
175
|
|
Overall Study
COMPLETED
|
173
|
169
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
| Measure |
Tivozanib Hydrochloride
Participants randomized to this arm received the study drug, tivozanib hydrochloride.
|
Sorafenib
Participants randomized to this arm received the comparator drug, sorafenib.
|
|---|---|---|
|
Overall Study
Randomized but not treated
|
2
|
6
|
Baseline Characteristics
A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC)
Baseline characteristics by cohort
| Measure |
Tivozanib Hydrochloride
n=175 Participants
Participants randomized to this arm received the study drug, tivozanib hydrochloride.
|
Sorafenib
n=175 Participants
Participants randomized to this arm received the comparator drug, sorafenib.
|
Total
n=350 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
126 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
254 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Age, Continuous
|
62 Years
n=5 Participants
|
63 Years
n=7 Participants
|
63 Years
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
165 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
332 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Non-white
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Previous therapies
Two VEGFR TKIs
|
79 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Previous therapies
Checkpoint inhibitor plus VEGFR TKI
|
47 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Previous therapies
VEGFR TKI plus other systemic agent
|
49 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
IMDC risk category
Favourable
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
IMDC risk category
Intermediate
|
109 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
IMDC risk category
Poor
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Disease progression was assessed every 8 weeks (up to approximately 5 years)Population: Intent-to-treat (ITT) Population included all randomized participants.
The PFS, as assessed by a blinded independent radiological review (IRR), is defined as the time from randomization to first documentation of objective tumor progression (progressive disease) or death due to any reasons whichever comes first. Disease progression per RECIST 1.1 criteria is defined 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 |
Tivozanib Hydrochloride
n=175 Participants
Participants randomized to this arm received the study drug, tivozanib hydrochloride.
|
Sorafenib
n=175 Participants
Participants randomized to this arm received the comparator drug, sorafenib.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
5.59 Months
Interval 5.29 to 7.33
|
3.88 Months
Interval 3.71 to 5.55
|
SECONDARY outcome
Timeframe: Date of randomization to date of death (up to approximately 5 years)Population: ITT Population
The OS is defined as the time from the date of randomization to date of death due to any cause.
Outcome measures
| Measure |
Tivozanib Hydrochloride
n=175 Participants
Participants randomized to this arm received the study drug, tivozanib hydrochloride.
|
Sorafenib
n=175 Participants
Participants randomized to this arm received the comparator drug, sorafenib.
|
|---|---|---|
|
Overall Survival (OS)
|
16.39 Months
Interval 13.44 to 22.21
|
19.15 Months
Interval 14.95 to 24.21
|
SECONDARY outcome
Timeframe: Every 8 weeks from date of randomization until disease progression (up to approximately 5 years)Population: ITT Population
The ORR is defined as the percentage of participants who have at least a 30% reduction in the sum of diameters per RECIST (Version 1.1).
Outcome measures
| Measure |
Tivozanib Hydrochloride
n=175 Participants
Participants randomized to this arm received the study drug, tivozanib hydrochloride.
|
Sorafenib
n=175 Participants
Participants randomized to this arm received the comparator drug, sorafenib.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
31 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Assessed every 8 weeks from date of randomization until date of progression (up to approximately 5 years)Population: ITT Population
The DOR is defined as the time from the first documentation of objective tumor response to the first documentation of tumor progression per RECIST 1.1 or to death due to any cause.
Outcome measures
| Measure |
Tivozanib Hydrochloride
n=175 Participants
Participants randomized to this arm received the study drug, tivozanib hydrochloride.
|
Sorafenib
n=175 Participants
Participants randomized to this arm received the comparator drug, sorafenib.
|
|---|---|---|
|
Duration of Response (DOR)
|
NA Months
Interval 12.91 to
The median and upper limit of the 95% confidence interval were not calculable because an insufficient number of participants reached the event.
|
5.65 Months
Interval 5.55 to
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event.
|
Adverse Events
Tivozanib Hydrochloride
Serious events: 81 serious events
Other events: 171 other events
Deaths: 114 deaths
Sorafenib
Serious events: 67 serious events
Other events: 170 other events
Deaths: 113 deaths
Serious adverse events
| Measure |
Tivozanib Hydrochloride
n=173 participants at risk
Participants randomized to this arm received the study drug, tivozanib hydrochloride.
|
Sorafenib
n=170 participants at risk
Participants randomized to this arm received the comparator drug, sorafenib.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.5%
6/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.7%
3/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
3/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
2/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial ulceration
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Infections and infestations
Pneumonia
|
3.5%
6/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
3.5%
6/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
3/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Infections and infestations
Influenza
|
1.2%
2/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Infections and infestations
Appendicitis
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Infections and infestations
Meningitis aseptic
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Infections and infestations
Post procedural infection
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.3%
4/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Nervous system disorders
Ischaemic stroke
|
1.2%
2/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.2%
2/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Nervous system disorders
Spinal cord compression
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Nervous system disorders
Altered state of consciousness
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Nervous system disorders
Brain compression
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Nervous system disorders
Dizziness
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Nervous system disorders
Paralysis
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Nervous system disorders
Coma
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Nervous system disorders
Frontal lobe epilepsy
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Gastrointestinal disorders
Vomiting
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
1.8%
3/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
1.2%
2/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Gastrointestinal disorders
Stomatitis
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Gastrointestinal disorders
Melaena
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.2%
2/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Gastrointestinal disorders
Anal ulcer
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
General disorders
Asthenia
|
1.7%
3/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
1.2%
2/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
General disorders
Pyrexia
|
1.2%
2/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
General disorders
Death
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
1.8%
3/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
General disorders
Pain
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
General disorders
Fatigue
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
General disorders
General physical health deterioration
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
General disorders
Performance status decreased
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.7%
3/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.2%
2/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.2%
2/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Hepatobiliary disorders
Cholangitis
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Hepatobiliary disorders
Jaundice
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
2.3%
4/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
2.4%
4/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.2%
2/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spinal cord
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Psychiatric disorders
Confusional state
|
1.7%
3/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Psychiatric disorders
Depression
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Psychiatric disorders
Disorientation
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Psychiatric disorders
Mental disorder
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.7%
3/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Renal and urinary disorders
Renal failure
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
1.2%
2/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Renal and urinary disorders
Haematuria
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Cardiac disorders
Cardiac failure
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Cardiac disorders
Atrial fibrillation
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Cardiac disorders
Myocardial infarction
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
2.9%
5/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
1.2%
2/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
1.2%
2/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Vascular disorders
Hypertension
|
1.2%
2/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Vascular disorders
Arteriosclerosis
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Vascular disorders
Deep vein thrombosis
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
1.2%
2/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Ear and labyrinth disorders
Vertigo
|
1.2%
2/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
1.2%
2/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
1.8%
3/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
1.2%
2/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Surgical and medical procedures
Rehabilitation therapy
|
0.00%
0/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Cardiac disorders
Cardiac arrest
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Nervous system disorders
Headache
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Nervous system disorders
Seizure
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Renal and urinary disorders
Renal impairment
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.00%
0/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
Other adverse events
| Measure |
Tivozanib Hydrochloride
n=173 participants at risk
Participants randomized to this arm received the study drug, tivozanib hydrochloride.
|
Sorafenib
n=170 participants at risk
Participants randomized to this arm received the comparator drug, sorafenib.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
42.8%
74/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
53.5%
91/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Gastrointestinal disorders
Stomatitis
|
20.8%
36/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
22.4%
38/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Gastrointestinal disorders
Nausea
|
29.5%
51/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
18.2%
31/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Gastrointestinal disorders
Vomiting
|
17.9%
31/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
14.7%
25/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.1%
21/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
9.4%
16/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
General disorders
Fatigue
|
37.0%
64/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
24.1%
41/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
General disorders
Asthenia
|
32.4%
56/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
23.5%
40/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Vascular disorders
Hypertension
|
42.2%
73/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
30.0%
51/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
27.2%
47/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
9.4%
16/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
39.3%
68/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
30.0%
51/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
16.2%
28/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
40.6%
69/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.8%
17/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
24.7%
42/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.4%
11/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
5.3%
9/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.5%
6/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
21.8%
37/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.7%
3/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
7.1%
12/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.3%
4/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
11.8%
20/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
6.5%
11/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.58%
1/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
5.3%
9/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Investigations
Weight decreased
|
17.3%
30/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
21.8%
37/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
6.9%
12/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
1.2%
2/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Nervous system disorders
Dizziness
|
9.8%
17/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
4.7%
8/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Endocrine disorders
Hypothyroidism
|
17.9%
31/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
7.6%
13/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Renal and urinary disorders
Proteinuria
|
9.8%
17/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
3.5%
6/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
General disorders
Oedema peripheral
|
9.2%
16/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
7.1%
12/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
General disorders
Pyrexia
|
7.5%
13/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
10.6%
18/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.4%
18/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
7.1%
12/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Gastrointestinal disorders
Constipation
|
11.0%
19/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
18.2%
31/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.2%
16/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
1.8%
3/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.5%
25/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
10.0%
17/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.0%
38/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
15.3%
26/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.5%
32/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
15.3%
26/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.4%
18/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
8.8%
15/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.4%
18/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
6.5%
11/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.9%
12/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
4.1%
7/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.2%
9/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
2.4%
4/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.9%
12/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
3.5%
6/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.3%
4/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
5.9%
10/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Investigations
Blood creatinine increased
|
7.5%
13/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
1.2%
2/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Nervous system disorders
Headache
|
11.6%
20/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
9.4%
16/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Nervous system disorders
Dysgeusia
|
5.8%
10/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
4.7%
8/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Infections and infestations
Nasopharyngitis
|
6.9%
12/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Infections and infestations
Urinary tract infection
|
4.0%
7/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
6.5%
11/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Blood and lymphatic system disorders
Anaemia
|
9.8%
17/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
13.5%
23/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Vascular disorders
Hypotension
|
5.2%
9/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
1.2%
2/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Investigations
Lipase increased
|
5.2%
9/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
2.4%
4/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Investigations
Aspartate aminotransferase increased
|
5.2%
9/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
1.8%
3/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.2%
9/173 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
0.59%
1/170 • From first dose to last dose plus 30 days (up to approximately 5 years)
Serious treatment-emergent adverse events and other (non-serious) treatment-emergent adverse events in Safety Population (all participants who received at least 1 dose of study drug) are reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place