Trial Outcomes & Findings for A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer (NCT NCT02202746)
NCT ID: NCT02202746
Last Updated: 2020-06-23
Results Overview
The primary efficacy endpoint of PFS was calculated as 1+ the number of days from the date of first dose of study drug to disease progression or death due to any cause, whichever occurs first. Patients without a documented event of progression were censored on the date of their last adequate tumor assessment (i.e., radiologic assessment), or the date of randomization if no tumor assessments were performed. Progression events were determined by the investigator. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), at least a 20% increase in the sum of the longest diameter 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. The appearance of one or more new lesions is also considered progression.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
178 participants
Primary outcome timeframe
From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 29 months
Results posted on
2020-06-23
Participant Flow
178 patients were recruited from 32 sites in the United States.
Participant milestones
| Measure |
Lucitanib (CO-3810) 10 mg QD
10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
Lucitanib (CO-3810) 15 mg QD
15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
|---|---|---|
|
Overall Study
STARTED
|
109
|
69
|
|
Overall Study
COMPLETED
|
109
|
69
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Lucitanib (CO-3810) 10 mg QD
n=109 Participants
10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
Lucitanib (CO-3810) 15 mg QD
n=69 Participants
15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
Total
n=178 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.0 years
n=5 Participants
|
53.0 years
n=7 Participants
|
55.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
87 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
10 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not provided
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown/Not assessed
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
97 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Provided
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Number of Prior Anticancer Therapies
|
6.0 Therapies
n=5 Participants
|
6.0 Therapies
n=7 Participants
|
6.0 Therapies
n=5 Participants
|
|
Fibroblast Growth Factor (FGF) Status
11q
|
34 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Fibroblast Growth Factor (FGF) Status
FGFR1
|
50 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Fibroblast Growth Factor (FGF) Status
FGFR1 & 11q
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Fibroblast Growth Factor (FGF) Status
Negative
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 29 monthsPopulation: Efficacy population: all patients who have received at least one dose of lucitanib and are confirmed as FGR1-, 11q-amplified, or FGF non-amplified per the central laboratory
The primary efficacy endpoint of PFS was calculated as 1+ the number of days from the date of first dose of study drug to disease progression or death due to any cause, whichever occurs first. Patients without a documented event of progression were censored on the date of their last adequate tumor assessment (i.e., radiologic assessment), or the date of randomization if no tumor assessments were performed. Progression events were determined by the investigator. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), at least a 20% increase in the sum of the longest diameter 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. The appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Lucitanib (CO-3810) 10 mg QD
n=107 Participants
10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
Lucitanib (CO-3810) 15 mg QD
n=67 Participants
15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
All Patients
The total efficacy population analyzed for response
|
|---|---|---|---|
|
Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by the Investigator
|
93 Days
Interval 78.0 to 140.0
|
77 Days
Interval 50.0 to 86.0
|
—
|
SECONDARY outcome
Timeframe: From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 29 monthsPopulation: Efficacy population: all patients who have received at least one dose of lucitanib and are confirmed as FGR1-, 11q-amplified, or FGF non-amplified per the central laboratory
ORR is the percentage of patients with a best response of CR or PR according to RECIST v1.1. The best response is recorded from the start of the treatment (Day 1) until disease progression or recurrence. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
Outcome measures
| Measure |
Lucitanib (CO-3810) 10 mg QD
n=106 Participants
10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
Lucitanib (CO-3810) 15 mg QD
n=67 Participants
15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
All Patients
n=173 Participants
The total efficacy population analyzed for response
|
|---|---|---|---|
|
Objective Response Rate (ORR) by RECIST v1.1
|
4.7 percentage of participants
|
1.5 percentage of participants
|
3.5 percentage of participants
|
SECONDARY outcome
Timeframe: From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 29 monthsPopulation: Efficacy population for patients who had a confirmed CR or PR
DR for complete response (CR) and partial response (PR) was measured from the date that any of these best confirmed responses was first recorded until the first date that PD was objectively documented. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
Outcome measures
| Measure |
Lucitanib (CO-3810) 10 mg QD
n=5 Participants
10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
Lucitanib (CO-3810) 15 mg QD
n=1 Participants
15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
All Patients
The total efficacy population analyzed for response
|
|---|---|---|---|
|
Duration of Response (DR) by RECIST v1.1
|
175 Days
Interval 44.0 to 209.0
|
336 Days
Interval 336.0 to 336.0
|
—
|
SECONDARY outcome
Timeframe: From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 29 monthsPopulation: Efficacy population only
The DCR is defined as the percentage of patients with a best response rate of CR, PR, or SD for at least 12 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since the treatment started.
Outcome measures
| Measure |
Lucitanib (CO-3810) 10 mg QD
n=106 Participants
10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
Lucitanib (CO-3810) 15 mg QD
n=67 Participants
15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
All Patients
n=173 Participants
The total efficacy population analyzed for response
|
|---|---|---|---|
|
Disease Control Rate (DCR) by RECIST v1.1
|
48.1 percentage of patients
|
34.3 percentage of patients
|
42.8 percentage of patients
|
SECONDARY outcome
Timeframe: Study Day -7 to Study Day 1, or approximately 8 daysPopulation: PK parameters were assessed in a subset of patients (N=15)
The comparative PK study was a within-patient comparison of tablet and capsule formulations of lucitanib administered orally. PK sampling was performed at specified time points on each of the following two days: • Day -7: patients received a single administration of 10 mg or 15 mg lucitanib tablet formulation • Day 1: patients received a single administration of 10 mg or 15 mg lucitanib in capsule formulation. Cmax = maximum concentration following administration of lucitanib.
Outcome measures
| Measure |
Lucitanib (CO-3810) 10 mg QD
n=9 Participants
10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
Lucitanib (CO-3810) 15 mg QD
n=6 Participants
15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
All Patients
The total efficacy population analyzed for response
|
|---|---|---|---|
|
Comparative Pharmacokinetics (PK) of the Lucitanib Capsule Formulation vs. Tablet Formulation - Cmax
Tablet
|
292 ng/mL
Standard Deviation 156
|
278 ng/mL
Standard Deviation 99.8
|
—
|
|
Comparative Pharmacokinetics (PK) of the Lucitanib Capsule Formulation vs. Tablet Formulation - Cmax
Capsule
|
265 ng/mL
Standard Deviation 137
|
285 ng/mL
Standard Deviation 121
|
—
|
SECONDARY outcome
Timeframe: Study Day -7 to Study Day 1, or approximately 8 daysPopulation: PK parameters were assessed in a subset of patients (N=15)
The comparative PK study was a within-patient comparison of tablet and capsule formulations of lucitanib administered orally. PK sampling was performed at specified time points on each of the following two days: • Day -7: patients received a single administration of 10 mg or 15 mg lucitanib tablet formulation • Day 1: patients received a single administration of 10 mg or 15 mg lucitanib in capsule formulation. Tmax = time to maximum concentration following administration of lucitanib
Outcome measures
| Measure |
Lucitanib (CO-3810) 10 mg QD
n=9 Participants
10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
Lucitanib (CO-3810) 15 mg QD
n=6 Participants
15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
All Patients
The total efficacy population analyzed for response
|
|---|---|---|---|
|
Comparative Pharmacokinetics (PK) of the Lucitanib Capsule Formulation vs. Tablet Formulation - Tmax
Tablet
|
1.0 Hours
Interval 0.5 to 4.0
|
1.0 Hours
Interval 0.5 to 2.5
|
—
|
|
Comparative Pharmacokinetics (PK) of the Lucitanib Capsule Formulation vs. Tablet Formulation - Tmax
Capsule
|
1.5 Hours
Interval 1.0 to 4.0
|
1.0 Hours
Interval 1.0 to 2.5
|
—
|
SECONDARY outcome
Timeframe: Study Day -7 to Study Day 1, or approximately 8 daysPopulation: PK parameters were assessed in a subset of patients (N=15)
The comparative PK study was a within-patient comparison of tablet and capsule formulations of lucitanib administered orally. PK sampling was performed at specified time points on each of the following two days: • Day -7: patients received a single administration of 10 mg or 15 mg lucitanib tablet formulation • Day 1: patients received a single administration of 10 mg or 15 mg lucitanib in capsule formulation. AUClast = area under the plasma concentration time curve from time 0 to the last quantifiable time point (24 hour)
Outcome measures
| Measure |
Lucitanib (CO-3810) 10 mg QD
n=9 Participants
10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
Lucitanib (CO-3810) 15 mg QD
n=6 Participants
15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
All Patients
The total efficacy population analyzed for response
|
|---|---|---|---|
|
Comparative Pharmacokinetics (PK) of the Lucitanib Capsule Formulation vs. Tablet Formulation - AUClast
Tablet
|
2550 h*ng/mL
Standard Deviation 1150
|
2840 h*ng/mL
Standard Deviation 1230
|
—
|
|
Comparative Pharmacokinetics (PK) of the Lucitanib Capsule Formulation vs. Tablet Formulation - AUClast
Capsule
|
2650 h*ng/mL
Standard Deviation 1380
|
2420 h*ng/mL
Standard Deviation 613
|
—
|
SECONDARY outcome
Timeframe: Study Day -7 to Study Day 1, or approximately 8 daysPopulation: PK parameters were assessed in a subset of patients (N=15)
The comparative PK study was a within-patient comparison of tablet and capsule formulations of lucitanib administered orally. PK sampling was performed at specified time points on each of the following two days: • Day -7: patients received a single administration of 10 mg or 15 mg lucitanib tablet formulation • Day 1: patients received a single administration of 10 mg or 15 mg lucitanib in capsule formulation. AUCinf = area under the plasma concentration time curve from 0 to infinity
Outcome measures
| Measure |
Lucitanib (CO-3810) 10 mg QD
n=9 Participants
10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
Lucitanib (CO-3810) 15 mg QD
n=6 Participants
15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
All Patients
The total efficacy population analyzed for response
|
|---|---|---|---|
|
Comparative Pharmacokinetics (PK) of the Lucitanib Capsule Formulation vs. Tablet Formulation - AUCinf
Tablet
|
4780 h*ng/mL
Standard Deviation 2140
|
5720 h*ng/mL
Standard Deviation 3760
|
—
|
|
Comparative Pharmacokinetics (PK) of the Lucitanib Capsule Formulation vs. Tablet Formulation - AUCinf
Capsule
|
5680 h*ng/mL
Standard Deviation 2730
|
4620 h*ng/mL
Standard Deviation 1620
|
—
|
SECONDARY outcome
Timeframe: Study Day -7 to Study Day 1, or approximately 8 daysPopulation: PK parameters were assessed in a subset of patients (N=15).
Relative bioavailability of lucitanib was evaluated by comparison of (log-transformed) AUClast, Cmax and AUCinf of the tablet formulation to the capsule formulation using an analysis of variance (ANOVA) model with treatment as a fixed effect. The geometric means, ratio of the geometric means and 90% confidence intervals (CI) on the ratio of Tablet to Capsule (T:R) were presented for AUClast, Cmax and AUCinf. The CIs on the ratio of untransformed PK parameters were derived through reverse transformation of the 90% CI of the difference in the log scale to the 90% CI of the ratio in the original scale.
Outcome measures
| Measure |
Lucitanib (CO-3810) 10 mg QD
n=9 Participants
10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
Lucitanib (CO-3810) 15 mg QD
n=6 Participants
15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
All Patients
The total efficacy population analyzed for response
|
|---|---|---|---|
|
Relative Bioavailability Analysis for Tablet vs Capsule - Cmax, AUClast, AUCinf
Cmax Geometric Mean Ratio
|
111.73 Percentage (tablet/capsule)
Interval 70.35 to 177.45
|
100.56 Percentage (tablet/capsule)
Interval 64.59 to 156.55
|
—
|
|
Relative Bioavailability Analysis for Tablet vs Capsule - Cmax, AUClast, AUCinf
AUClast Geometric Mean Ratio
|
97.58 Percentage (tablet/capsule)
Interval 60.61 to 157.09
|
112.2 Percentage (tablet/capsule)
Interval 78.73 to 159.89
|
—
|
|
Relative Bioavailability Analysis for Tablet vs Capsule - Cmax, AUClast, AUCinf
AUCinf Geometric Mean Ratio
|
82.9 Percentage (tablet/capsule)
Interval 51.75 to 132.81
|
114.23 Percentage (tablet/capsule)
Interval 70.09 to 186.15
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 to date of death, assessed up to 29 monthsPopulation: Intent to treat population by initial treatment and overall
Overall survival (OS) is defined as the number of days from the date of first dose of study drug to the date of death (due to any cause). Patients without a known date of death will be censored on the date the patient was last known to be alive.
Outcome measures
| Measure |
Lucitanib (CO-3810) 10 mg QD
n=109 Participants
10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
Lucitanib (CO-3810) 15 mg QD
n=69 Participants
15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
All Patients
n=178 Participants
The total efficacy population analyzed for response
|
|---|---|---|---|
|
Overall Survival
|
15.0 Months
Interval 10.7 to 17.3
|
7.7 Months
Interval 6.1 to 10.3
|
10.7 Months
Interval 8.5 to 13.7
|
SECONDARY outcome
Timeframe: From Cycle 1 Day 1 until end of treatment, assessed up to 29 monthsPopulation: Efficacy Population defined as all patients who have received at least one dose of Lucitanib and have at least one post-baseline Investigator Overall Objective Tumor Assessment. 'Overall Number of Participants Analyzed'=participants who completed both a baseline FACT-B assessment and at least one post-baseline assessment.
FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 37 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (10 items) ranging from 0 to 40; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. FACT-B Total Score is derived from adding the five subscale scores. Total possible score ranges from 0 to 148. High scale score represents a better QoL.
Outcome measures
| Measure |
Lucitanib (CO-3810) 10 mg QD
n=80 Participants
10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
Lucitanib (CO-3810) 15 mg QD
n=46 Participants
15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
All Patients
n=126 Participants
The total efficacy population analyzed for response
|
|---|---|---|---|
|
Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Total Score
|
-2.422 units on a scale
Standard Deviation 15.5134
|
-7.586 units on a scale
Standard Deviation 17.0709
|
-4.307 units on a scale
Standard Deviation 16.2248
|
Adverse Events
Lucitanib (CO-3810) 10 mg QD
Serious events: 31 serious events
Other events: 107 other events
Deaths: 5 deaths
Lucitanib (CO-3810) 15 mg QD
Serious events: 22 serious events
Other events: 69 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Lucitanib (CO-3810) 10 mg QD
n=109 participants at risk
10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
Lucitanib (CO-3810) 15 mg QD
n=69 participants at risk
15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.92%
1/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
0.00%
0/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Cardiac disorders
Sinus tachycardia
|
0.92%
1/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
0.00%
0/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.92%
1/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
0.00%
0/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Dysphagia
|
1.8%
2/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
0.00%
0/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.92%
1/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Nausea
|
0.92%
1/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
2.9%
2/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.92%
1/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
0.00%
0/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
2.9%
2/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
General disorders
Mucosal inflammation
|
0.00%
0/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
General disorders
Pyrexia
|
0.92%
1/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
0.00%
0/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.92%
1/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
0.00%
0/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Atypical pneumonia
|
0.92%
1/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
0.00%
0/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Cellulitis
|
0.92%
1/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
0.00%
0/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Pneumonia
|
1.8%
2/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Urinary tract infection
|
0.92%
1/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Investigations
Alanine aminotransferase increased
|
0.92%
1/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
0.00%
0/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Investigations
Ammonia increased
|
0.00%
0/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Investigations
Aspartate aminotransferase increased
|
0.92%
1/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
0.00%
0/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Investigations
Blood bilirubin increased
|
0.92%
1/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
0.00%
0/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Investigations
Platelet count decreased
|
0.00%
0/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.92%
1/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.92%
1/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
0.00%
0/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.8%
3/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.92%
1/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
0.00%
0/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.92%
1/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
0.00%
0/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
4.6%
5/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
7.2%
5/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Aphasia
|
0.00%
0/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Headache
|
1.8%
2/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
0.00%
0/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Migraine
|
0.92%
1/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
0.00%
0/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Psychiatric disorders
Mental status changes
|
0.92%
1/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
0.00%
0/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Renal and urinary disorders
Renal tubular acidosis
|
0.92%
1/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
0.00%
0/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
2/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.92%
1/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
4.3%
3/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.8%
2/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.92%
1/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Vascular disorders
Hypertension
|
1.8%
2/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
2.9%
2/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Vascular disorders
Hypertensive crisis
|
0.92%
1/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
0.00%
0/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
Other adverse events
| Measure |
Lucitanib (CO-3810) 10 mg QD
n=109 participants at risk
10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
Lucitanib (CO-3810) 15 mg QD
n=69 participants at risk
15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.6%
5/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
8.7%
6/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
5.8%
4/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.3%
8/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
13.0%
9/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Endocrine disorders
Hypothyroidism
|
37.6%
41/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
49.3%
34/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Eye disorders
Vision blurred
|
6.4%
7/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
4.3%
3/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
9/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
8.7%
6/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Abdominal pain
|
14.7%
16/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
13.0%
9/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.6%
5/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
8.7%
6/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Constipation
|
18.3%
20/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
17.4%
12/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Diarrhoea
|
30.3%
33/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
27.5%
19/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Dry mouth
|
10.1%
11/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
7.2%
5/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Dyspepsia
|
9.2%
10/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
5.8%
4/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Nausea
|
48.6%
53/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
47.8%
33/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Gastrointestinal disorders
Vomiting
|
32.1%
35/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
34.8%
24/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
General disorders
Fatigue
|
50.5%
55/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
53.6%
37/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
General disorders
Mucosal inflammation
|
2.8%
3/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
5.8%
4/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
General disorders
Oedema peripheral
|
11.9%
13/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
5.8%
4/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
General disorders
Pain
|
6.4%
7/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
4.3%
3/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
General disorders
Pyrexia
|
7.3%
8/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
2.9%
2/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Sinusitis
|
5.5%
6/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
4/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
5.8%
4/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Infections and infestations
Urinary tract infection
|
12.8%
14/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
14.5%
10/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
9/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
5.8%
4/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Investigations
Aspartate aminotransferase increased
|
9.2%
10/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
5.8%
4/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Investigations
Blood alkaline phosphatase increased
|
8.3%
9/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
4.3%
3/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Investigations
Blood bilirubin increased
|
5.5%
6/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
5.8%
4/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Investigations
Blood thyroid stimulating hormone increased
|
5.5%
6/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
2.9%
2/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Investigations
Ejection fraction decreased
|
2.8%
3/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
7.2%
5/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Investigations
Platelet count decreased
|
3.7%
4/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
8.7%
6/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Investigations
Weight decreased
|
7.3%
8/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
7.2%
5/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.0%
36/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
30.4%
21/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Dehydration
|
7.3%
8/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
2.9%
2/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.3%
9/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
4.3%
3/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.3%
9/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
13.0%
9/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.9%
13/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
17.4%
12/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.5%
18/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
13.0%
9/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Psychiatric disorders
Anxiety
|
6.4%
7/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
8.7%
6/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.5%
6/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
2.9%
2/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.5%
6/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
7.2%
5/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.3%
8/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
2.9%
2/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.8%
3/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
7.2%
5/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.4%
7/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
1.4%
1/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Psychiatric disorders
Depression
|
7.3%
8/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
10.1%
7/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.6%
5/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
5.8%
4/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
4.6%
5/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
7.2%
5/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Dizziness
|
13.8%
15/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
7.2%
5/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Dysgeusia
|
4.6%
5/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
5.8%
4/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Nervous system disorders
Headache
|
38.5%
42/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
34.8%
24/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Psychiatric disorders
Insomnia
|
10.1%
11/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
8.7%
6/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Renal and urinary disorders
Haematuria
|
2.8%
3/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
8.7%
6/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Renal and urinary disorders
Proteinuria
|
20.2%
22/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
31.9%
22/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.4%
19/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
10.1%
7/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.2%
22/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
20.3%
14/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.7%
4/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
5.8%
4/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.5%
6/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
11.6%
8/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.6%
5/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
8.7%
6/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.92%
1/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
5.8%
4/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Vascular disorders
Hot flush
|
4.6%
5/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
5.8%
4/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
|
Vascular disorders
Hypertension
|
78.0%
85/109 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
72.5%
50/69 • Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
|
Additional Information
Medical Information Department
Clovis Oncology, Inc.
Phone: +1 415 409 7220
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee All parties agree to submit all manuscripts or abstracts to all other parties 30 days prior to submission. This will enable all parties to protect proprietary information and to provide comments based on information that may not yet be available to other parties. The sponsor may request a delay in publication if there are important intellectual property concerns relating to publication, but does not have the right to suppress publication of the study results indefinitely.
- Publication restrictions are in place
Restriction type: OTHER