Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Rivoceranib in Participants With Recurrent or Metastatic Adenoid Cystic Carcinoma (ACC) (NCT NCT04119453)
NCT ID: NCT04119453
Last Updated: 2026-07-30
Results Overview
Complete Response - Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm) (the sum may not be "0" if there are target nodes). Partial Response - At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
Up to 41 months
Results posted on
2026-07-30
Participant Flow
Participants were enrolled at sites in the United States and South Korea.
Participant milestones
| Measure |
Rivoceranib
Participants received 700 milligrams (mg) rivoceranib once daily as oral tablets during 28-day continuous cycles.
|
|---|---|
|
Overall Study
STARTED
|
80
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
80
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
80
|
Reasons for withdrawal
| Measure |
Rivoceranib
Participants received 700 milligrams (mg) rivoceranib once daily as oral tablets during 28-day continuous cycles.
|
|---|---|
|
Overall Study
Death
|
44
|
|
Overall Study
Withdrawal by Subject
|
10
|
|
Overall Study
Study terminated by sponsor
|
12
|
|
Overall Study
Other reasons
|
14
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Rivoceranib in Participants With Recurrent or Metastatic Adenoid Cystic Carcinoma (ACC)
Baseline characteristics by cohort
| Measure |
Rivoceranib
n=80 Participants
Participants received 700 mg rivoceranib once daily as oral tablets during 28-day continuous cycles.
|
|---|---|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 11.78 • n=20 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
28 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Up to 41 monthsPopulation: The Intent-to-treat population included all participants enrolled in the study.
Complete Response - Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm) (the sum may not be "0" if there are target nodes). Partial Response - At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Rivoceranib
n=80 Participants
Participants received 700 mg rivoceranib once daily as oral tablets during 28-day continuous cycles.
|
|---|---|
|
Objective Response Rate (ORR): Percentage of Participants Who Achieved Confirmed Complete Response (CR) or Partial Response (PR) Per the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator/Institutional Assessment
|
13.8 percentage of participants
Interval 7.1 to 23.3
|
PRIMARY outcome
Timeframe: Up to 41 monthsPopulation: The Intent-to-treat population included all participants enrolled in the study.
CR - Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (the sum may not be "0" if there are target nodes). PR - At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Rivoceranib
n=80 Participants
Participants received 700 mg rivoceranib once daily as oral tablets during 28-day continuous cycles.
|
|---|---|
|
ORR: Percentage of Participants Who Achieve Confirmed CR or PR Per RECIST 1.1 by Independent Central Review
|
8.8 percentage of participants
Interval 3.6 to 17.2
|
SECONDARY outcome
Timeframe: Months 12 and 24Population: The Intent-to-treat population included all participants enrolled in the study.
OS was defined as the interval from the start of study therapy to death from any cause. Here, the percentage of participants with OS at specified time points are shown.
Outcome measures
| Measure |
Rivoceranib
n=80 Participants
Participants received 700 mg rivoceranib once daily as oral tablets during 28-day continuous cycles.
|
|---|---|
|
Overall Survival (OS) Rate
Month 24
|
51.5 percentage of participants
Interval 39.2 to 62.4
|
|
Overall Survival (OS) Rate
Month 12
|
74.7 percentage of participants
Interval 62.9 to 83.3
|
SECONDARY outcome
Timeframe: Months 6, 12, and 24Population: The Intent-to-treat population included all participants enrolled in the study. Here, "Number analyzed" is the number of participants who have neither experienced a PFS event nor been censored before that time point.
PFS was defined as the time from the start of treatment with rivoceranib to the first evaluation showing Progressive Disease (PD) or death, whichever occurred first. Participants who did not experience PD or death were censored at the date of last disease assessment. Here, the percentage of participants with PFS at the given timepoints is shown. PD - At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)
Outcome measures
| Measure |
Rivoceranib
n=80 Participants
Participants received 700 mg rivoceranib once daily as oral tablets during 28-day continuous cycles.
|
|---|---|
|
Progression Free Survival (PFS) Rate at 6 Months, 12 Months, and 2 Years by Investigator or Institutional Assessment
Month 6
|
74.1 percentage of participants
Interval 62.1 to 82.9
|
|
Progression Free Survival (PFS) Rate at 6 Months, 12 Months, and 2 Years by Investigator or Institutional Assessment
Month 12
|
37.3 percentage of participants
Interval 22.5 to 49.0
|
|
Progression Free Survival (PFS) Rate at 6 Months, 12 Months, and 2 Years by Investigator or Institutional Assessment
Month 24
|
8.9 percentage of participants
Interval 3.3 to 17.9
|
SECONDARY outcome
Timeframe: Months 6 and 12, and Year 2Population: The Intent-to-treat population included all participants enrolled in the study. Here, "Number analyzed" is the number of participants who have neither experienced a PFS event nor been censored before that time point.
PFS was defined as the time from the start of treatment with rivoceranib to the first evaluation showing PD or death, whichever occured first. Participants who do not experience PD or death were censored at the date of last disease assessment. Here, the percentage of participants with PFS at the given timepoints is shown. PD - At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)
Outcome measures
| Measure |
Rivoceranib
n=80 Participants
Participants received 700 mg rivoceranib once daily as oral tablets during 28-day continuous cycles.
|
|---|---|
|
Progression Free Survival (PFS) at 6 Months, 12 Months, and 2 Years Evaluated by Independent Central Review
Month 6
|
78.3 percentage of participants
Interval 66.0 to 86.6
|
|
Progression Free Survival (PFS) at 6 Months, 12 Months, and 2 Years Evaluated by Independent Central Review
Month 12
|
37.4 percentage of participants
Interval 24.6 to 50.2
|
SECONDARY outcome
Timeframe: Up to 41 monthsPopulation: The efficacy evaluable population consisted of eligible participants treated with at least one dose of rivoceranib who had at least one post baseline tumor assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Duration of response was the time from the first response of PR or CR (which was subsequently confirmed) to the first evaluation showing PD or death, whichever occurred first. Death due to any cause was considered in the determination of DOR. CR - Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (the sum may not be "0" if there are target nodes). PR - At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD - At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)
Outcome measures
| Measure |
Rivoceranib
n=11 Participants
Participants received 700 mg rivoceranib once daily as oral tablets during 28-day continuous cycles.
|
|---|---|
|
Duration of Response (DoR) Per RECIST Version 1.1 by Investigator or Institutional Assessment
|
14.9 months
Interval 4.9 to
Upper 95% CI was not evaluable due to insufficient number of events
|
SECONDARY outcome
Timeframe: Up to 41 monthsPopulation: The efficacy evaluable population consisted of eligible participants treated with at least one dose of rivoceranib who had at least one post baseline tumor assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Duration of response was the time from the first response of PR or CR (which was subsequently confirmed) to the first evaluation showing PD or death, whichever occurred first. Death due to any cause was considered in the determination of DOR. CR - Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (the sum may not be "0" if there are target nodes). PR - At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD - At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)
Outcome measures
| Measure |
Rivoceranib
n=7 Participants
Participants received 700 mg rivoceranib once daily as oral tablets during 28-day continuous cycles.
|
|---|---|
|
Duration of Response (DoR) Per RECIST Version 1.1 Evaluated by Independent Central Review
|
7.2 months
Interval 3.5 to 8.4
|
SECONDARY outcome
Timeframe: Up to 41 monthsPopulation: The efficacy evaluable population consisted of eligible participants treated with at least one dose of rivoceranib who had at least one post baseline tumor assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
TTP was the length of time from the start of treatment with rivoceranib until objective tumor progression. At the time of analysis of TTP, any participants who do not experience PD including participants who died without PD were censored at the date of last disease assessment. The TTP was estimated using the Kaplan-Meier method. PD - At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)
Outcome measures
| Measure |
Rivoceranib
n=72 Participants
Participants received 700 mg rivoceranib once daily as oral tablets during 28-day continuous cycles.
|
|---|---|
|
Time to Progression (TTP) Per RECIST Version 1.1 by Investigator or Institutional Assessment
|
9.2 months
Interval 8.5 to 13.7
|
SECONDARY outcome
Timeframe: Up to 41 monthsPopulation: The efficacy evaluable population consisted of eligible participants treated with at least one dose of rivoceranib who had at least one post baseline tumor assessment. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
TTP was the length of time from the start of treatment with rivoceranib until objective tumor progression. At the time of analysis of TTP, any participants who do not experience PD including participants who died without PD were censored at the date of last disease assessment. The TTP was estimated using the Kaplan-Meier method. PD - At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)
Outcome measures
| Measure |
Rivoceranib
n=72 Participants
Participants received 700 mg rivoceranib once daily as oral tablets during 28-day continuous cycles.
|
|---|---|
|
TTP Per RECIST Version 1.1 Evaluated by Independent Central Review
|
9.3 months
Interval 8.5 to 13.6
|
SECONDARY outcome
Timeframe: From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)Population: The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
Rivoceranib
n=80 Participants
Participants received 700 mg rivoceranib once daily as oral tablets during 28-day continuous cycles.
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs)
|
80 Participants
|
Adverse Events
Rivoceranib
Serious events: 32 serious events
Other events: 80 other events
Deaths: 44 deaths
Serious adverse events
| Measure |
Rivoceranib
n=80 participants at risk
Participants received 700 mg rivoceranib once daily as oral tablets in continuous 28-day cycles.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.0%
4/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.8%
3/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Stomatitis
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Dysphagia
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Faecaloma
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Ileus paralytic
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Oesophageal perforation
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Oral cavity fistula
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Pneumonia
|
3.8%
3/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Bronchitis viral
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
COVID-19
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Osteomyelitis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Parotitis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Sinusitis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
3/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Seizure
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Somnolence
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Syncope
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
General disorders
Fatigue
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
General disorders
Non-cardiac chest pain
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Renal and urinary disorders
Urinary fistula
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Vascular disorders
Embolism
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Vascular disorders
Hypotension
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Hepatobiliary disorders
Cholangitis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Injury, poisoning and procedural complications
Wound complication
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Psychiatric disorders
Mental status changes
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
Other adverse events
| Measure |
Rivoceranib
n=80 participants at risk
Participants received 700 mg rivoceranib once daily as oral tablets in continuous 28-day cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
13.8%
11/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Cardiac disorders
Palpitations
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
3.8%
3/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Cardiac disorders
Bradycardia
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Cardiac disorders
Intracardiac thrombus
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Cardiac disorders
Sinus bradycardia
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Cardiac disorders
Sinus tachycardia
|
3.8%
3/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Cardiac disorders
Tachycardia
|
5.0%
4/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Ear and labyrinth disorders
Ear discomfort
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Ear and labyrinth disorders
Ear pain
|
3.8%
3/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Ear and labyrinth disorders
Hypoacusis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Ear and labyrinth disorders
Meniere's disease
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Ear and labyrinth disorders
Otorrhoea
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Ear and labyrinth disorders
Vertigo
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
8/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Eye disorders
Conjunctival oedema
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Eye disorders
Diplopia
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Eye disorders
Dry eye
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Eye disorders
Eye oedema
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Eye disorders
Eye pain
|
3.8%
3/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Eye disorders
Lacrimation increased
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Eye disorders
Periorbital oedema
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Eye disorders
Retinopathy
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Eye disorders
Vision blurred
|
3.8%
3/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Eye disorders
Visual impairment
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Abdominal pain
|
21.2%
17/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Anal inflammation
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Angular cheilitis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Chapped lips
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Constipation
|
31.2%
25/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Defaecation urgency
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Diarrhoea
|
43.8%
35/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Dry mouth
|
16.2%
13/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Dyschezia
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.8%
11/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Dysphagia
|
7.5%
6/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Flatulence
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
15.0%
12/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Gingival bleeding
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Glossodynia
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Lip pain
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
6.2%
5/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Mucous stools
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Nausea
|
53.8%
43/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Oral cavity fistula
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Oral discomfort
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
5.0%
4/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Oral pain
|
21.2%
17/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Periodontal disease
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Proctalgia
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Proctitis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Stomatitis
|
50.0%
40/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Swollen tongue
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Tongue haemorrhage
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Toothache
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
20/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
General disorders
Asthenia
|
6.2%
5/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
General disorders
Chills
|
3.8%
3/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
General disorders
Face oedema
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
General disorders
Facial pain
|
5.0%
4/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
General disorders
Fatigue
|
61.3%
49/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
General disorders
Gait disturbance
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
General disorders
Influenza like illness
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
General disorders
Malaise
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
General disorders
Non-cardiac chest pain
|
6.2%
5/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
General disorders
Oedema peripheral
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
General disorders
Pain
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
General disorders
Pyrexia
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
General disorders
Temperature intolerance
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Hepatobiliary disorders
Cholangitis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Hepatobiliary disorders
Cholelithiasis
|
3.8%
3/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Immune system disorders
Contrast media allergy
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Immune system disorders
Contrast media reaction
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
COVID-19
|
3.8%
3/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Dacryocanaliculitis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Epiglottitis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Gastroenteritis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Herpes simplex
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Herpes zoster
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Hordeolum
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Infected cyst
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Influenza
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Ludwig angina
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Myringitis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Oral candidiasis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Osteomyelitis
|
3.8%
3/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Otitis externa
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Paronychia
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Parotitis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Periodontitis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Pneumonia
|
5.0%
4/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Rash pustular
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
SARS-CoV-2 viraemia
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Sinusitis
|
5.0%
4/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Skin infection
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Soft tissue infection
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Tinea pedis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Tooth infection
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Tracheobronchitis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
4/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
5/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Viraemia
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Infections and infestations
Wound infection
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Injury, poisoning and procedural complications
Fall
|
3.8%
3/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Injury, poisoning and procedural complications
Gastrostomy tube site complication
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Injury, poisoning and procedural complications
Osteoradionecrosis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Injury, poisoning and procedural complications
Stoma site discomfort
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Injury, poisoning and procedural complications
Wound
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Injury, poisoning and procedural complications
Wound complication
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
20/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
Amylase increased
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
Aspartate aminotransferase increased
|
27.5%
22/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
Blood alkaline phosphatase increased
|
12.5%
10/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
Blood bilirubin increased
|
15.0%
12/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
Blood chloride decreased
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
Blood cholesterol increased
|
5.0%
4/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
Blood creatinine increased
|
6.2%
5/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
Blood lactic acid increased
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
Blood sodium decreased
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
Breath sounds abnormal
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
Ejection fraction decreased
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
Electrocardiogram QT prolonged
|
6.2%
5/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
International normalised ratio increased
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
Lipase increased
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
Liver function test increased
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
Lymphocyte count decreased
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
Neutrophil count decreased
|
8.8%
7/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
Platelet count decreased
|
16.2%
13/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
Protein urine present
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
Staphylococcus test positive
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
Transaminases increased
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
Urine leukocyte esterase positive
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
Weight decreased
|
31.2%
25/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Investigations
White blood cell count decreased
|
5.0%
4/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
37.5%
30/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.5%
6/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.2%
5/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.2%
5/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
10/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.0%
8/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Metabolism and nutrition disorders
Hypophagia
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
10.0%
8/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.2%
13/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
20/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.8%
3/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
15.0%
12/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.2%
9/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
5/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthropathy
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.5%
6/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
5.0%
4/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Ageusia
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Amnesia
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Dizziness
|
12.5%
10/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Dysarthria
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Dysgeusia
|
5.0%
4/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Encephalopathy
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Headache
|
52.5%
42/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Hypoaesthesia
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Ischaemic stroke
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Memory impairment
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Neuropathy peripheral
|
3.8%
3/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Paraesthesia
|
5.0%
4/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Parosmia
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Presyncope
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Restless legs syndrome
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Sciatica
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Seizure
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Somnolence
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Taste disorder
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Nervous system disorders
Tremor
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Psychiatric disorders
Anger
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Psychiatric disorders
Anxiety
|
6.2%
5/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Psychiatric disorders
Confusional state
|
3.8%
3/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Psychiatric disorders
Delirium
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Psychiatric disorders
Depression
|
3.8%
3/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Psychiatric disorders
Hallucination
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Psychiatric disorders
Insomnia
|
6.2%
5/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Psychiatric disorders
Restlessness
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Renal and urinary disorders
Bladder pain
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Renal and urinary disorders
Dysuria
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Renal and urinary disorders
Glycosuria
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Renal and urinary disorders
Haematuria
|
8.8%
7/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Renal and urinary disorders
Proteinuria
|
40.0%
32/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Renal and urinary disorders
Renal haemorrhage
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Renal and urinary disorders
Urinary retention
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Reproductive system and breast disorders
Adnexa uteri cyst
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Reproductive system and breast disorders
Breast haematoma
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Reproductive system and breast disorders
Penile pain
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.2%
9/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
18.8%
15/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
22.5%
18/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
10/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.8%
3/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
10/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.5%
6/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary pain
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
5/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Skin and subcutaneous tissue disorders
Blister
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
5.0%
4/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
4/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
33.8%
27/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Skin and subcutaneous tissue disorders
Plantar erythema
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
4/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.0%
12/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.8%
3/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Skin and subcutaneous tissue disorders
Skin sensitisation
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Vascular disorders
Embolism
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Vascular disorders
Hot flush
|
2.5%
2/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Vascular disorders
Hypertension
|
66.2%
53/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Vascular disorders
Hypotension
|
1.2%
1/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.8%
3/80 • From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
The Safety Population included all participants enrolled in the study who received at least one dose of rivoceranib.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place