Trial Outcomes & Findings for Study to Assess the Long-term Safety of Lenvatinib Monotherapy, a Lenvatinib Combination Regimen, or a Comparator Treatment Arm to Cancer Participants in Eisai Sponsored Lenvatinib Trials (NCT NCT03477175)
NCT ID: NCT03477175
Last Updated: 2025-01-07
Results Overview
A treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study informed consent form (ICF), or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous. A serious adverse event (SAE) was any untoward medical occurrence that at any dose: resulted in death; life threatening condition; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or was medically important due to other reasons than the mentioned criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Up to 58.8 months in current study
Results posted on
2025-01-07
Participant Flow
Participants took part in the study at 28 investigative sites in China, United States, Australia, Belgium, Germany, Italy, South Korea, Netherlands, Poland, Romania, and Thailand from 16 August 2018 to 21 December 2023.
A total of 40 participants were screened and enrolled to receive study treatment in this rollover study. The study was to consist of Cohorts A, B and C; however, no participants met criteria for Cohorts B or C, so no participants were enrolled in these cohorts and hence no data were collected and reported for these cohorts. As pre-specified in statistical analysis plan (SAP), data were collected and reported by regions (China and Rest of World) in this study for all sections.
Participant milestones
| Measure |
Cohort A, China: Lenvatinib Monotherapy
Participants from China who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study (E7080-C086-108 \[NCT03009292\], or E7080-C086-308 \[NCT02966093\]) received lenvatinib dose ranging from 4 milligram (mg) to 24 mg, capsules, orally until progressive disease (PD), unacceptable toxicity, participant's discontinued study, use of nonpermitted concomitant drug, unacceptable noncompliance with the protocol, or lost to follow-up.
|
Cohort A, Rest of the World: Lenvatinib Monotherapy
Participants from rest of the world who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study (E7080-E044-101 \[NCT00121719\], E7080-A001-109 \[NCT02686164\], E7080-G000-201 \[NCT00784303\], E7080-G000-303 \[NCT01321554\], E7080-C086-108 \[NCT03009292\], or E7080-C086-308 \[NCT02966093\]) received lenvatinib dose ranging from 4 mg to 24 mg, capsules, orally until PD, unacceptable toxicity, participant's discontinued study, use of nonpermitted concomitant drug, unacceptable noncompliance with the protocol, or lost to follow-up.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
21
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
19
|
21
|
Reasons for withdrawal
| Measure |
Cohort A, China: Lenvatinib Monotherapy
Participants from China who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study (E7080-C086-108 \[NCT03009292\], or E7080-C086-308 \[NCT02966093\]) received lenvatinib dose ranging from 4 milligram (mg) to 24 mg, capsules, orally until progressive disease (PD), unacceptable toxicity, participant's discontinued study, use of nonpermitted concomitant drug, unacceptable noncompliance with the protocol, or lost to follow-up.
|
Cohort A, Rest of the World: Lenvatinib Monotherapy
Participants from rest of the world who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study (E7080-E044-101 \[NCT00121719\], E7080-A001-109 \[NCT02686164\], E7080-G000-201 \[NCT00784303\], E7080-G000-303 \[NCT01321554\], E7080-C086-108 \[NCT03009292\], or E7080-C086-308 \[NCT02966093\]) received lenvatinib dose ranging from 4 mg to 24 mg, capsules, orally until PD, unacceptable toxicity, participant's discontinued study, use of nonpermitted concomitant drug, unacceptable noncompliance with the protocol, or lost to follow-up.
|
|---|---|---|
|
Overall Study
Unable to travel due to COVID-19
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Transitioned to commercial drug
|
6
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Adverse Event
|
1
|
5
|
|
Overall Study
Disease Progression
|
7
|
7
|
Baseline Characteristics
Study to Assess the Long-term Safety of Lenvatinib Monotherapy, a Lenvatinib Combination Regimen, or a Comparator Treatment Arm to Cancer Participants in Eisai Sponsored Lenvatinib Trials
Baseline characteristics by cohort
| Measure |
Cohort A, China: Lenvatinib Monotherapy
n=19 Participants
Participants from China who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study (E7080-C086-108 \[NCT03009292\], or E7080-C086-308 \[NCT02966093\]) received lenvatinib dose ranging from 4 mg to 24 mg, capsules, orally until PD, unacceptable toxicity, participant's discontinued study, use of nonpermitted concomitant drug, unacceptable noncompliance with the protocol, or lost to follow-up.
|
Cohort A, Rest of the World: Lenvatinib Monotherapy
n=21 Participants
Participants from rest of the world who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study (E7080-E044-101 \[NCT00121719\], E7080-A001-109 \[NCT02686164\], E7080-G000-201 \[NCT00784303\], E7080-G000-303 \[NCT01321554\], E7080-C086-108 \[NCT03009292\], or E7080-C086-308 \[NCT02966093\]) received lenvatinib dose ranging from 4 mg to 24 mg, capsules, orally until PD, unacceptable toxicity, participant's discontinued study, use of nonpermitted concomitant drug, unacceptable noncompliance with the protocol, or lost to follow-up.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.2 years
STANDARD_DEVIATION 8.17 • n=5 Participants
|
62.7 years
STANDARD_DEVIATION 11.45 • n=7 Participants
|
59.6 years
STANDARD_DEVIATION 10.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 58.8 months in current studyPopulation: Safety analysis set included the group of participants who received at least 1 dose of study drug.
A treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study informed consent form (ICF), or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous. A serious adverse event (SAE) was any untoward medical occurrence that at any dose: resulted in death; life threatening condition; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or was medically important due to other reasons than the mentioned criteria.
Outcome measures
| Measure |
Cohort A, China: Lenvatinib Monotherapy
n=19 Participants
Participants from China who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study (E7080-C086-108 \[NCT03009292\], or E7080-C086-308 \[NCT02966093\]) received lenvatinib dose ranging from 4 mg to 24 mg, capsules, orally until PD, unacceptable toxicity, participant's discontinued study, use of nonpermitted concomitant drug, unacceptable noncompliance with the protocol, or lost to follow-up.
|
Cohort A, Rest of the World: Lenvatinib Monotherapy
n=21 Participants
Participants from rest of the world who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study (E7080-E044-101 \[NCT00121719\], E7080-A001-109 \[NCT02686164\], E7080-G000-201 \[NCT00784303\], E7080-G000-303 \[NCT01321554\], E7080-C086-108 \[NCT03009292\], or E7080-C086-308 \[NCT02966093\]) received lenvatinib dose ranging from 4 mg to 24 mg, capsules, orally until PD, unacceptable toxicity, participant's discontinued study, use of nonpermitted concomitant drug, unacceptable noncompliance with the protocol, or lost to follow-up.
|
|---|---|---|
|
Number of Participants With Any Treatment-Emergent Serious Adverse Events (TESAEs)
|
7 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Up to 58.8 months in current studyPopulation: Safety analysis set included the group of participants who received at least 1 dose of study drug.
A TEAE was defined as an AE that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study in ICF, or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous. A non-serious TEAE was any AE that was not considered a serious adverse event.
Outcome measures
| Measure |
Cohort A, China: Lenvatinib Monotherapy
n=19 Participants
Participants from China who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study (E7080-C086-108 \[NCT03009292\], or E7080-C086-308 \[NCT02966093\]) received lenvatinib dose ranging from 4 mg to 24 mg, capsules, orally until PD, unacceptable toxicity, participant's discontinued study, use of nonpermitted concomitant drug, unacceptable noncompliance with the protocol, or lost to follow-up.
|
Cohort A, Rest of the World: Lenvatinib Monotherapy
n=21 Participants
Participants from rest of the world who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study (E7080-E044-101 \[NCT00121719\], E7080-A001-109 \[NCT02686164\], E7080-G000-201 \[NCT00784303\], E7080-G000-303 \[NCT01321554\], E7080-C086-108 \[NCT03009292\], or E7080-C086-308 \[NCT02966093\]) received lenvatinib dose ranging from 4 mg to 24 mg, capsules, orally until PD, unacceptable toxicity, participant's discontinued study, use of nonpermitted concomitant drug, unacceptable noncompliance with the protocol, or lost to follow-up.
|
|---|---|---|
|
Number of Participants With Any Non-Serious Treatment-Emergent Adverse Events (TEAEs)
|
18 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: Up to 58.8 months in current studyPopulation: Safety analysis set included the group of participants who received at least 1 dose of study drug.
A TEAE was defined as an AE that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study ICF, or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous. Related TEAE was defined as AE with causal relationship between the study drug and the TEAE.
Outcome measures
| Measure |
Cohort A, China: Lenvatinib Monotherapy
n=19 Participants
Participants from China who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study (E7080-C086-108 \[NCT03009292\], or E7080-C086-308 \[NCT02966093\]) received lenvatinib dose ranging from 4 mg to 24 mg, capsules, orally until PD, unacceptable toxicity, participant's discontinued study, use of nonpermitted concomitant drug, unacceptable noncompliance with the protocol, or lost to follow-up.
|
Cohort A, Rest of the World: Lenvatinib Monotherapy
n=21 Participants
Participants from rest of the world who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study (E7080-E044-101 \[NCT00121719\], E7080-A001-109 \[NCT02686164\], E7080-G000-201 \[NCT00784303\], E7080-G000-303 \[NCT01321554\], E7080-C086-108 \[NCT03009292\], or E7080-C086-308 \[NCT02966093\]) received lenvatinib dose ranging from 4 mg to 24 mg, capsules, orally until PD, unacceptable toxicity, participant's discontinued study, use of nonpermitted concomitant drug, unacceptable noncompliance with the protocol, or lost to follow-up.
|
|---|---|---|
|
Number of Participants With Treatment-Related TEAEs
|
15 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Up to 58.8 months in current studyPopulation: Safety analysis set included the group of participants who received at least 1 dose of study drug.
A TEAE was defined as an AE that emerged during the treatment in the current roll-over study, having been absent prior to the time the participant signed the current roll-over study ICF, or re-emerged during treatment in the current roll-over study after having been present but resolved before signing the ICF or worsened in severity during treatment in the current roll-over study relative to the pre-ICF state, when the AE was continuous.
Outcome measures
| Measure |
Cohort A, China: Lenvatinib Monotherapy
n=19 Participants
Participants from China who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study (E7080-C086-108 \[NCT03009292\], or E7080-C086-308 \[NCT02966093\]) received lenvatinib dose ranging from 4 mg to 24 mg, capsules, orally until PD, unacceptable toxicity, participant's discontinued study, use of nonpermitted concomitant drug, unacceptable noncompliance with the protocol, or lost to follow-up.
|
Cohort A, Rest of the World: Lenvatinib Monotherapy
n=21 Participants
Participants from rest of the world who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study (E7080-E044-101 \[NCT00121719\], E7080-A001-109 \[NCT02686164\], E7080-G000-201 \[NCT00784303\], E7080-G000-303 \[NCT01321554\], E7080-C086-108 \[NCT03009292\], or E7080-C086-308 \[NCT02966093\]) received lenvatinib dose ranging from 4 mg to 24 mg, capsules, orally until PD, unacceptable toxicity, participant's discontinued study, use of nonpermitted concomitant drug, unacceptable noncompliance with the protocol, or lost to follow-up.
|
|---|---|---|
|
Number of Participants With Any TEAE
|
18 Participants
|
20 Participants
|
Adverse Events
Cohort A, China: Lenvatinib Monotherapy
Serious events: 7 serious events
Other events: 18 other events
Deaths: 2 deaths
Cohort A, Rest of the World: Lenvatinib Monotherapy
Serious events: 14 serious events
Other events: 17 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Cohort A, China: Lenvatinib Monotherapy
n=19 participants at risk
Participants from China who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study (E7080-C086-108 \[NCT03009292\], or E7080-C086-308 \[NCT02966093\]) received lenvatinib dose ranging from 4 mg to 24 mg, capsules, orally until PD, unacceptable toxicity, participant's discontinued study, use of nonpermitted concomitant drug, unacceptable noncompliance with the protocol, or lost to follow-up.
|
Cohort A, Rest of the World: Lenvatinib Monotherapy
n=21 participants at risk
Participants from rest of the world who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study (E7080-E044-101 \[NCT00121719\], E7080-A001-109 \[NCT02686164\], E7080-G000-201 \[NCT00784303\], E7080-G000-303 \[NCT01321554\], E7080-C086-108 \[NCT03009292\], or E7080-C086-308 \[NCT02966093\]) received lenvatinib dose ranging from 4 mg to 24 mg, capsules, orally until PD, unacceptable toxicity, participant's discontinued study, use of nonpermitted concomitant drug, unacceptable noncompliance with the protocol, or lost to follow-up.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
9.5%
2/21 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
9.5%
2/21 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.3%
1/19 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
5.3%
1/19 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Seizure
|
5.3%
1/19 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.3%
1/19 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Cohort A, China: Lenvatinib Monotherapy
n=19 participants at risk
Participants from China who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study (E7080-C086-108 \[NCT03009292\], or E7080-C086-308 \[NCT02966093\]) received lenvatinib dose ranging from 4 mg to 24 mg, capsules, orally until PD, unacceptable toxicity, participant's discontinued study, use of nonpermitted concomitant drug, unacceptable noncompliance with the protocol, or lost to follow-up.
|
Cohort A, Rest of the World: Lenvatinib Monotherapy
n=21 participants at risk
Participants from rest of the world who received lenvatinib monotherapy or who crossed over from a comparator arm to receive lenvatinib monotherapy in their parent study (E7080-E044-101 \[NCT00121719\], E7080-A001-109 \[NCT02686164\], E7080-G000-201 \[NCT00784303\], E7080-G000-303 \[NCT01321554\], E7080-C086-108 \[NCT03009292\], or E7080-C086-308 \[NCT02966093\]) received lenvatinib dose ranging from 4 mg to 24 mg, capsules, orally until PD, unacceptable toxicity, participant's discontinued study, use of nonpermitted concomitant drug, unacceptable noncompliance with the protocol, or lost to follow-up.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
1/19 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.8%
3/19 • Number of events 17 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
19.0%
4/21 • Number of events 11 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gingival disorder
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gingival pain
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
9.5%
2/21 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
5.3%
1/19 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
General disorders
Peripheral swelling
|
5.3%
1/19 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
9.5%
2/21 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
21.1%
4/19 • Number of events 4 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
9.5%
2/21 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.5%
2/19 • Number of events 4 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
9.5%
2/21 • Number of events 5 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
21.1%
4/19 • Number of events 5 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Investigations
Albumin globulin ratio decreased
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Investigations
Amylase increased
|
5.3%
1/19 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Investigations
Apolipoprotein A-I decreased
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
21.1%
4/19 • Number of events 7 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Investigations
Bile acids increased
|
5.3%
1/19 • Number of events 3 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
10.5%
2/19 • Number of events 3 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Investigations
Blood bicarbonate decreased
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
10.5%
2/19 • Number of events 5 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 3 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Investigations
Blood fibrinogen decreased
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Investigations
Blood urea increased
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
10.5%
2/19 • Number of events 7 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Investigations
Haematocrit decreased
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Investigations
Lipase increased
|
5.3%
1/19 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Investigations
Low density lipoprotein increased
|
5.3%
1/19 • Number of events 4 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil count increased
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Investigations
Platelet count increased
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Investigations
Platelet-large cell ratio decreased
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Investigations
Protein total decreased
|
5.3%
1/19 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Investigations
Urinary occult blood positive
|
10.5%
2/19 • Number of events 4 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
23.8%
5/21 • Number of events 9 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
15.8%
3/19 • Number of events 6 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
5.3%
1/19 • Number of events 3 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
15.8%
3/19 • Number of events 9 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.3%
1/19 • Number of events 4 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.5%
2/19 • Number of events 3 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.3%
1/19 • Number of events 3 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.3%
1/19 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
14.3%
3/21 • Number of events 3 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
9.5%
2/21 • Number of events 5 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
5.3%
1/19 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
9.5%
2/21 • Number of events 4 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
9.5%
2/21 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Albuminuria
|
21.1%
4/19 • Number of events 13 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
14.3%
3/21 • Number of events 4 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
31.6%
6/19 • Number of events 13 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 5 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
5.3%
1/19 • Number of events 3 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Vulvovaginal inflammation
|
5.3%
1/19 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
19.0%
4/21 • Number of events 4 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
4.8%
1/21 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.3%
1/19 • Number of events 1 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
10.5%
2/19 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
5.3%
1/19 • Number of events 3 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/19 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
9.5%
2/21 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
5.3%
1/19 • Number of events 2 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
10.5%
2/19 • Number of events 4 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
0.00%
0/21 • Up to 58.8 months in current study
Safety analysis set included the group of participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place