Trial Outcomes & Findings for Study of Lenvatinib (E7080) in Unresectable Biliary Tract Cancer (BTC) Who Failed Gemcitabine-based Combination Chemotherapy (NCT NCT02579616)
NCT ID: NCT02579616
Last Updated: 2020-12-23
Results Overview
ORR was assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. ORR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR). Confirmation of CR or PR was performed at least 28 days following the initial achievement of the response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
From the date of first dose of study drug to the date of last documentation of disease progression or date of death from any cause, whichever occurred first (up to approximately 1 year 1 month)
Results posted on
2020-12-23
Participant Flow
Participants took part in the study at 7 investigative sites in Japan from 23 Oct 2015 to 27 Feb 2019.
A total of 29 participants were screened and enrolled, of which 3 were screen failures and 26 were treated in the study.
Participant milestones
| Measure |
Lenvatinib 24 mg
Participants received lenvatinib 24 milligram (mg) capsules, orally, once daily in 28-days treatment cycles until disease progression, adverse events (AEs), withdrawal of consent, or participant's choice (up to Cycle 40).
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
Treated
|
26
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Lenvatinib 24 mg
Participants received lenvatinib 24 milligram (mg) capsules, orally, once daily in 28-days treatment cycles until disease progression, adverse events (AEs), withdrawal of consent, or participant's choice (up to Cycle 40).
|
|---|---|
|
Overall Study
Participants did not receive treatment
|
3
|
Baseline Characteristics
Study of Lenvatinib (E7080) in Unresectable Biliary Tract Cancer (BTC) Who Failed Gemcitabine-based Combination Chemotherapy
Baseline characteristics by cohort
| Measure |
Lenvatinib 24 mg
n=26 Participants
Participants received lenvatinib 24 mg capsules, orally, once daily in 28-days treatment cycles until disease progression, AEs, withdrawal of consent, or participant's choice (up to Cycle 40).
|
|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 9.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the date of first dose of study drug to the date of last documentation of disease progression or date of death from any cause, whichever occurred first (up to approximately 1 year 1 month)Population: The FAS included the group of participants who received at least one dose of study drug.
ORR was assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. ORR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR). Confirmation of CR or PR was performed at least 28 days following the initial achievement of the response.
Outcome measures
| Measure |
Lenvatinib 24 mg
n=26 Participants
Participants received lenvatinib 24 mg capsules, orally, once daily in 28-days treatment cycles until disease progression, AEs, withdrawal of consent, or participant's choice (up to Cycle 40).
|
|---|---|
|
Objective Response Rate (ORR)
|
11.5 percentage of participant
Interval 2.4 to 30.2
|
SECONDARY outcome
Timeframe: From the date of first dose to the date of last documentation of disease progression or death from any cause, whichever occurred first (up to Week 12)Population: The FAS included the group of participants who received at least one dose of study drug.
PFS was assessed by the investigator based on RECIST 1.1. PFS was defined as the time from the date of first dose to the date of last documentation of disease progression or death from any cause, whichever occurred first. PFS rate was cumulative probability for event-free participants at 12 weeks. PFS rate at 12 weeks was calculated using Kaplan-Meier method.
Outcome measures
| Measure |
Lenvatinib 24 mg
n=26 Participants
Participants received lenvatinib 24 mg capsules, orally, once daily in 28-days treatment cycles until disease progression, AEs, withdrawal of consent, or participant's choice (up to Cycle 40).
|
|---|---|
|
Progression-free Survival (PFS) Rate at 12 Weeks
|
72.2 percentage of participant
Interval 50.4 to 85.7
|
SECONDARY outcome
Timeframe: From the date of first dose of study drug to the date of last documentation of disease progression or date of death from any cause, whichever occurred first (up to approximately 3 years 4 months)Population: The FAS included the group of participants who received at least one dose of study drug.
PFS was assessed by the investigator based on RECIST 1.1. PFS was defined as the time from the date of first dose to the date of last documentation of disease progression or date of death from any cause, whichever occurred first. For participants who did not have an event, PFS were censored. PFS was calculated using Kaplan-Meier method.
Outcome measures
| Measure |
Lenvatinib 24 mg
n=26 Participants
Participants received lenvatinib 24 mg capsules, orally, once daily in 28-days treatment cycles until disease progression, AEs, withdrawal of consent, or participant's choice (up to Cycle 40).
|
|---|---|
|
Progression-free Survival (PFS)
|
3.19 months
Interval 2.79 to 7.23
|
SECONDARY outcome
Timeframe: From the date of first dose of study drug to the date of death from any cause (up to approximately 3 years 4 months)Population: The FAS included the group of participants who received at least one dose of study drug.
OS was defined as the time from the date of first dose to the date of death from any cause. For the participants who were alive or unknown, OS was censored on the last date participant was known to be event-free or date of data-cut-off. OS was calculated using the Kaplan-Meier method.
Outcome measures
| Measure |
Lenvatinib 24 mg
n=26 Participants
Participants received lenvatinib 24 mg capsules, orally, once daily in 28-days treatment cycles until disease progression, AEs, withdrawal of consent, or participant's choice (up to Cycle 40).
|
|---|---|
|
Overall Survival (OS)
|
7.35 months
Interval 4.5 to 11.27
|
SECONDARY outcome
Timeframe: From the date of first dose of study drug to the date of last documentation of disease progression or date of death from any cause, whichever occurred first (up to approximately 3 years 4 months)Population: The FAS included the group of participants who received at least one dose of study drug.
DCR was assessed by the investigator based on RECIST 1.1. DCR was defined as the percentage of participants whose BOR was CR, PR or SD.
Outcome measures
| Measure |
Lenvatinib 24 mg
n=26 Participants
Participants received lenvatinib 24 mg capsules, orally, once daily in 28-days treatment cycles until disease progression, AEs, withdrawal of consent, or participant's choice (up to Cycle 40).
|
|---|---|
|
Disease Control Rate (DCR)
|
84.6 percentage of participant
Interval 65.1 to 95.6
|
SECONDARY outcome
Timeframe: From the date of first dose of study drug to the date of the last documentation of disease progression or death from any cause, whichever occurred first (up to approximately 3 years 4 months)Population: The FAS included the group of participants who received at least one dose of study drug.
CBR was assessed by the investigator based on RECIST 1.1.CBR was defined as percentage of participants with BOR of CR, PR or durable SD. Durable SD: Durable SD: duration of SD greater than or equal to (\>=23) weeks.
Outcome measures
| Measure |
Lenvatinib 24 mg
n=26 Participants
Participants received lenvatinib 24 mg capsules, orally, once daily in 28-days treatment cycles until disease progression, AEs, withdrawal of consent, or participant's choice (up to Cycle 40).
|
|---|---|
|
Clinical Benefit Rate (CBR)
|
38.5 percentage of participant
Interval 20.2 to 59.4
|
SECONDARY outcome
Timeframe: From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)Population: The safety analysis set included group of participants who received at least one dose of study drug.
Outcome measures
| Measure |
Lenvatinib 24 mg
n=26 Participants
Participants received lenvatinib 24 mg capsules, orally, once daily in 28-days treatment cycles until disease progression, AEs, withdrawal of consent, or participant's choice (up to Cycle 40).
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
26 participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
18 participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: 0.5-2 hours post dose (Cycle length is 28 days)Population: The safety analysis set included group of participants who received at least one dose of study drug. The safety analysis set was used for plasma lenvatinib concentration calculation.
Outcome measures
| Measure |
Lenvatinib 24 mg
n=26 Participants
Participants received lenvatinib 24 mg capsules, orally, once daily in 28-days treatment cycles until disease progression, AEs, withdrawal of consent, or participant's choice (up to Cycle 40).
|
|---|---|
|
Plasma Concentrations of Lenvatinib
|
3.90 nanogram per milliliter (ng/mL)
Interval to 782.0
The lower limit value was not estimable as it was below the limit of quantification.
|
Adverse Events
Lenvatinib 24 mg
Serious events: 18 serious events
Other events: 26 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Lenvatinib 24 mg
n=26 participants at risk
Participants received lenvatinib 24 mg capsules, orally, once daily in 28-days treatment cycles until disease progression, AEs, withdrawal of consent, or participant's choice (up to Cycle 40).
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Hepatobiliary disorders
Bile duct obstruction
|
7.7%
2/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Hepatobiliary disorders
Bile duct stenosis
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Hepatobiliary disorders
Cholangitis
|
15.4%
4/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Hepatobiliary disorders
Cholecystitis 1
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Hepatobiliary disorders
Haemobilia
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Infections and infestations
Biliary tract infection
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Infections and infestations
Lung abscess
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Infections and infestations
Urinary tract infection
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.7%
2/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Psychiatric disorders
Completed suicide
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Renal and urinary disorders
Hydronephrosis
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Renal and urinary disorders
Renal impairment 1
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
Other adverse events
| Measure |
Lenvatinib 24 mg
n=26 participants at risk
Participants received lenvatinib 24 mg capsules, orally, once daily in 28-days treatment cycles until disease progression, AEs, withdrawal of consent, or participant's choice (up to Cycle 40).
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
23.1%
6/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
11.5%
3/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
53.8%
14/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Endocrine disorders
Hypoparathyroidism
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Endocrine disorders
Hypothyroidism
|
46.2%
12/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Eye disorders
Conjunctival haemorrhage 1
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Gastrointestinal disorders
Abdominal distension
|
7.7%
2/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
23.1%
6/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Gastrointestinal disorders
Ascites
|
15.4%
4/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Gastrointestinal disorders
Cheilitis
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Gastrointestinal disorders
Constipation
|
30.8%
8/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
30.8%
8/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Gastrointestinal disorders
Dry mouth
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Gastrointestinal disorders
Fistula of small intestine
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Gastrointestinal disorders
Nausea
|
23.1%
6/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Gastrointestinal disorders
Pancreatitis
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Gastrointestinal disorders
Stomatitis 4
|
15.4%
4/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Gastrointestinal disorders
Toothache
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Gastrointestinal disorders
Vomiting
|
11.5%
3/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
General disorders
Catheter site pain
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
General disorders
Face oedema
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
General disorders
Fatigue
|
50.0%
13/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
General disorders
Malaise
|
19.2%
5/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
General disorders
Medical device pain
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
General disorders
Mucosal inflammation
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
General disorders
Oedema peripheral
|
34.6%
9/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
General disorders
Pyrexia
|
30.8%
8/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Hepatobiliary disorders
Bile duct obstruction
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Hepatobiliary disorders
Cholangitis
|
11.5%
3/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
7.7%
2/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Infections and infestations
Angular cheilitis
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Infections and infestations
Bronchitis
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Infections and infestations
Fungal infection
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Infections and infestations
Gingivitis
|
7.7%
2/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Infections and infestations
Herpes zoster
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Infections and infestations
Influenza
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Infections and infestations
Liver abscess
|
7.7%
2/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Infections and infestations
Lung abscess
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
2/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Infections and infestations
Pneumonia
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Infections and infestations
Sepsis
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Infections and infestations
Sinusitis
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Investigations
Alanine aminotransferase increased
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Investigations
Amylase increased
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
2/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Investigations
Blood alkaline phosphatase increased
|
7.7%
2/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Investigations
Blood bilirubin increased
|
7.7%
2/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Investigations
Blood cholesterol increased
|
7.7%
2/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Investigations
Blood creatine phosphokinase increased
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Investigations
Blood creatinine increased
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Investigations
Blood lactate dehydrogenase increased
|
7.7%
2/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Investigations
Blood thyroid stimulating hormone increased
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Investigations
C-reactive protein increased
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Investigations
Thyroxine free increased
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Investigations
Tri-iodothyronine free increased
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Investigations
Weight decreased
|
30.8%
8/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
53.8%
14/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
11.5%
3/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
11.5%
3/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
2/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Musculoskeletal and connective tissue disorders
Enthesopathy
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
7.7%
2/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.4%
4/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
15.4%
4/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
15.4%
4/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Nervous system disorders
Akathisia
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Nervous system disorders
Dizziness
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Nervous system disorders
Dysgeusia
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Nervous system disorders
Headache
|
15.4%
4/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Nervous system disorders
Muscle spasticity
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Psychiatric disorders
Delirium
|
11.5%
3/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Psychiatric disorders
Depression
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Psychiatric disorders
Insomnia
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Renal and urinary disorders
Haematuria
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Renal and urinary disorders
Proteinuria
|
61.5%
16/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Renal and urinary disorders
Renal impairment
|
7.7%
2/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Renal and urinary disorders
Urinary tract obstruction
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
2/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
61.5%
16/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.5%
3/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
7.7%
2/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.7%
2/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.5%
3/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
57.7%
15/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.5%
3/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.1%
6/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.7%
2/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Vascular disorders
Hypertension
|
84.6%
22/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Vascular disorders
Hypotension
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
|
Vascular disorders
Orthostatic hypotension
|
3.8%
1/26 • From signing of informed consent form to 30 days after the decision to discontinue study treatment or 30 days after last dose of study drug, whichever comes later (up to approximately 3 years 4 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place