Trial Outcomes & Findings for Study of the Safety and Activity of Lenvatinib (E7080) in Subjects With KIF5B-RET-Positive Adenocarcinoma of the Lung (NCT NCT01877083)
NCT ID: NCT01877083
Last Updated: 2019-08-13
Results Overview
ORR was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), based on the investigator assessment of radiologic response according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. No independent review of tumor assessments was performed. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (\<) 10 millimeter (mm). PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
From first dose date until PD, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment (up to approximately 2 years 10 months)
Results posted on
2019-08-13
Participant Flow
Participants took part in the study at 14 investigative sites in the United States, Japan, Singapore, and Taiwan from 05 April 2013 to 2 November 2017.
A total of 25 participants with kinesin family 5B oncogene rearranged during transfection (KIF5B-RET)-positive adenocarcinoma of the lung or other RET translocations were enrolled and treated, 5 participants were ongoing in the Extension Phase at the time of data cut-off.
Participant milestones
| Measure |
Lenvatinib 24 mg
Participants with KIF5B-RET-positive adenocarcinoma and other RET translocations received lenvatinib 24 milligram (mg), capsule, orally, once daily in 28-day continuous cycles until disease progression (PD), development of unacceptable toxicity, withdrawal of consent, or termination of lenvatinib development by the sponsor.
|
|---|---|
|
Treatment Phase
STARTED
|
25
|
|
Treatment Phase
COMPLETED
|
5
|
|
Treatment Phase
NOT COMPLETED
|
20
|
|
Extension Phase
STARTED
|
5
|
|
Extension Phase
COMPLETED
|
0
|
|
Extension Phase
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Lenvatinib 24 mg
Participants with KIF5B-RET-positive adenocarcinoma and other RET translocations received lenvatinib 24 milligram (mg), capsule, orally, once daily in 28-day continuous cycles until disease progression (PD), development of unacceptable toxicity, withdrawal of consent, or termination of lenvatinib development by the sponsor.
|
|---|---|
|
Treatment Phase
Disease Progression
|
10
|
|
Treatment Phase
Clinical Progression
|
1
|
|
Treatment Phase
Adverse Event
|
6
|
|
Treatment Phase
Withdrawal by Subject
|
2
|
|
Treatment Phase
Lost to Follow-up
|
1
|
|
Extension Phase
Disease Progression
|
3
|
|
Extension Phase
Adverse Event
|
2
|
Baseline Characteristics
Study of the Safety and Activity of Lenvatinib (E7080) in Subjects With KIF5B-RET-Positive Adenocarcinoma of the Lung
Baseline characteristics by cohort
| Measure |
Lenvatinib 24 mg
n=25 Participants
Participants with KIF5B-RET-positive adenocarcinoma and other RET translocations received lenvatinib 24 mg, capsule, orally, once daily in 28-day continuous cycles until PD, development of unacceptable toxicity, withdrawal of consent, or termination of lenvatinib development by the sponsor.
|
|---|---|
|
Age, Continuous
|
60.0 Years
STANDARD_DEVIATION 13.40 • n=93 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From first dose date until PD, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment (up to approximately 2 years 10 months)Population: FAS included all participants who received at least 1 dose of lenvatinib.
ORR was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), based on the investigator assessment of radiologic response according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. No independent review of tumor assessments was performed. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (\<) 10 millimeter (mm). PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Lenvatinib 24 mg
n=25 Participants
Participants with KIF5B-RET-positive adenocarcinoma and other RET translocations received lenvatinib 24 mg, capsule, orally, once daily in 28-day continuous cycles until PD, development of unacceptable toxicity, withdrawal of consent, or termination of lenvatinib development by the sponsor.
|
|---|---|
|
Objective Response Rate (ORR)
|
16.0 percentage of participants
Interval 4.5 to 36.1
|
SECONDARY outcome
Timeframe: From first dose date until PD or death (up to approximately 2 years 10 months)Population: FAS included all participants who received at least 1 dose of lenvatinib.
PFS was defined as the time from the first dose to the date of first documentation of PD, or date of death, whichever occurred first. Tumor response data used to analyze PFS was obtained from the investigator's assessment of the imaging scans using RECIST 1.1. No independent review of tumor assessments were performed. PFS was calculated using Kaplan-Meier estimate and presented with 2-sided 95% Cl based on the Greenwood formula. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions.
Outcome measures
| Measure |
Lenvatinib 24 mg
n=23 Participants
Participants with KIF5B-RET-positive adenocarcinoma and other RET translocations received lenvatinib 24 mg, capsule, orally, once daily in 28-day continuous cycles until PD, development of unacceptable toxicity, withdrawal of consent, or termination of lenvatinib development by the sponsor.
|
|---|---|
|
Progression-free Survival (PFS)
|
7.3 months
Interval 3.6 to 10.2
|
SECONDARY outcome
Timeframe: From first dose date until date of death from any cause (approximately up to 2 years 10 months)Population: FAS included all participants who received at least 1 dose of lenvatinib.
OS was defined as the time from the date of first dose to the date of death from any cause. OS was calculated using Kaplan-Meier estimate and presented with 2-sided 95% Cl based on the Greenwood formula.
Outcome measures
| Measure |
Lenvatinib 24 mg
n=25 Participants
Participants with KIF5B-RET-positive adenocarcinoma and other RET translocations received lenvatinib 24 mg, capsule, orally, once daily in 28-day continuous cycles until PD, development of unacceptable toxicity, withdrawal of consent, or termination of lenvatinib development by the sponsor.
|
|---|---|
|
Overall Survival (OS)
|
NA months
Interval 5.8 to
Median and upper limit of confidence interval could not be calculated because higher number of participants were censored from analysis.
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: 0.5-4 hours, 6-10 hours postdose; Cycle 1 Day 15: predose, 0.5-4 hours, 6-10 hours postdose; Cycle 2 Day 1: predose, 2-12 hours postdose; Cycle 3 Day 1: predose; (Cycle length is equal to [=] 28 days)Population: The pharmacokinetic (PK) Analysis Set included all participants who received at least one dose of lenvatinib and had at least one quantifiable lenvatinib concentration. Participants who were evaluable at a particular time point for this outcome measure were included in the assessment.
Outcome measures
| Measure |
Lenvatinib 24 mg
n=24 Participants
Participants with KIF5B-RET-positive adenocarcinoma and other RET translocations received lenvatinib 24 mg, capsule, orally, once daily in 28-day continuous cycles until PD, development of unacceptable toxicity, withdrawal of consent, or termination of lenvatinib development by the sponsor.
|
|---|---|
|
Plasma Concentrations of Lenvatinib
Cycle 1 Day 15: predose
|
83.6 microgram per milliliter (mcg/mL)
Interval 31.0 to 201.0
|
|
Plasma Concentrations of Lenvatinib
Cycle 1 Day 1: 0.5 to 4 hours postdose
|
37.0 microgram per milliliter (mcg/mL)
Interval to 529.0
The lower range could not be calculated because concentration values were below level of quantification.
|
|
Plasma Concentrations of Lenvatinib
Cycle 1 Day 1: 6 to 10 hours postdose
|
278.5 microgram per milliliter (mcg/mL)
Interval 127.0 to 382.0
|
|
Plasma Concentrations of Lenvatinib
Cycle 1 Day 15: 0.5 to 4 hours postdose
|
89.2 microgram per milliliter (mcg/mL)
Interval 40.0 to 1390.0
|
|
Plasma Concentrations of Lenvatinib
Cycle 1 Day 15: 6 to 10 hours postdose
|
277.5 microgram per milliliter (mcg/mL)
Interval 59.0 to 684.0
|
|
Plasma Concentrations of Lenvatinib
Cycle 2 Day 1: predose
|
66.4 microgram per milliliter (mcg/mL)
Interval 21.0 to 272.0
|
|
Plasma Concentrations of Lenvatinib
Cycle 2 Day 1: 2 to 12 hours postdose
|
345.0 microgram per milliliter (mcg/mL)
Interval 110.0 to 576.0
|
|
Plasma Concentrations of Lenvatinib
Cycle 3 Day 1: predose
|
59.8 microgram per milliliter (mcg/mL)
Interval 27.0 to 522.0
|
Adverse Events
Lenvatinib 24 mg
Serious events: 16 serious events
Other events: 25 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Lenvatinib 24 mg
n=25 participants at risk
Participants with KIF5B-RET-positive adenocarcinoma and other RET translocations received lenvatinib 24 mg, capsule, orally, once daily in 28-day continuous cycles until PD, development of unacceptable toxicity, withdrawal of consent, or termination of lenvatinib development by the sponsor.
|
|---|---|
|
Cardiac disorders
Cardiac failure
|
4.0%
1/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Gastrointestinal disorders
Nausea
|
4.0%
1/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
1/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
General disorders
Malaise
|
4.0%
1/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
General disorders
Pyrexia
|
4.0%
1/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Hepatobiliary disorders
Cholecystitis acute
|
4.0%
1/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Infections and infestations
Device related sepsis
|
4.0%
1/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Infections and infestations
Pneumonia
|
12.0%
3/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Infections and infestations
Urinary tract infection
|
4.0%
1/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
12.0%
3/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Nervous system disorders
Transient ischaemic attack
|
4.0%
1/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Psychiatric disorders
Confusional state
|
4.0%
1/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
4.0%
1/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.0%
1/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.0%
1/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Infections and infestations
Bacterial infection
|
4.0%
1/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Renal and urinary disorders
Ureteric stenosis
|
4.0%
1/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Respiratory, thoracic and mediastinal disorders
Malignant pleural effusion
|
4.0%
1/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
Other adverse events
| Measure |
Lenvatinib 24 mg
n=25 participants at risk
Participants with KIF5B-RET-positive adenocarcinoma and other RET translocations received lenvatinib 24 mg, capsule, orally, once daily in 28-day continuous cycles until PD, development of unacceptable toxicity, withdrawal of consent, or termination of lenvatinib development by the sponsor.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Endocrine disorders
Hypothyroidism
|
12.0%
3/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Eye disorders
Dry eye
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
12.0%
3/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Gastrointestinal disorders
Constipation
|
24.0%
6/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
52.0%
13/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Gastrointestinal disorders
Dry mouth
|
16.0%
4/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Gastrointestinal disorders
Nausea
|
56.0%
14/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Gastrointestinal disorders
Oral pain
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Gastrointestinal disorders
Stomatitis
|
12.0%
3/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
10/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
General disorders
Fatigue
|
36.0%
9/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
General disorders
Generalised oedema
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
General disorders
Malaise
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
General disorders
Oedema peripheral
|
20.0%
5/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
General disorders
Pyrexia
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Infections and infestations
Pharyngitis
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Infections and infestations
Pneumonia
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Infections and infestations
Urinary tract infection
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
5/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Investigations
Aspartate aminotransferase increased
|
24.0%
6/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Investigations
Blood creatinine increased
|
12.0%
3/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Investigations
Neutrophil count decreased
|
12.0%
3/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Investigations
Platelet count decreased
|
28.0%
7/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Investigations
Weight decreased
|
20.0%
5/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Investigations
White blood cell count decreased
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
52.0%
13/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
16.0%
4/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
16.0%
4/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
20.0%
5/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
5/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.0%
3/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.0%
3/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Nervous system disorders
Dysgeusia
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Nervous system disorders
Headache
|
40.0%
10/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Psychiatric disorders
Anxiety
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Psychiatric disorders
Confusional state
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Psychiatric disorders
Depression
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Renal and urinary disorders
Proteinuria
|
48.0%
12/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.0%
6/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
12.0%
3/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.0%
4/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.0%
3/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.0%
4/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
12.0%
3/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.0%
3/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Vascular disorders
Hypertension
|
68.0%
17/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
|
Vascular disorders
Hypotension
|
8.0%
2/25 • From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 4 years 7 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER