Trial Outcomes & Findings for A Study of Nofazinlimab (CS1003) in Subjects With Advanced Hepatocellular Carcinoma (NCT NCT04194775)
NCT ID: NCT04194775
Last Updated: 2026-07-30
Results Overview
OS was defined as the time interval between the date of randomization to the date of death from any cause.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
534 participants
Primary outcome timeframe
From enrollment to end of follow-up, a median of 42.5 months
Results posted on
2026-07-30
Participant Flow
Participant milestones
| Measure |
Nofazinlimab + Lenvatinib
Nofazinlimab (200 mg) was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
Placebo + Lenvatinib
Placebo was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
|---|---|---|
|
Overall Study
STARTED
|
353
|
181
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
353
|
181
|
Reasons for withdrawal
| Measure |
Nofazinlimab + Lenvatinib
Nofazinlimab (200 mg) was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
Placebo + Lenvatinib
Placebo was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
|---|---|---|
|
Overall Study
Death
|
253
|
137
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
17
|
7
|
|
Overall Study
Treatment ongoing
|
28
|
7
|
|
Overall Study
Alive in follow-up
|
51
|
28
|
Baseline Characteristics
A Study of Nofazinlimab (CS1003) in Subjects With Advanced Hepatocellular Carcinoma
Baseline characteristics by cohort
| Measure |
Nofazinlimab + Lenvatinib
n=353 Participants
Nofazinlimab (200 mg) was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
Placebo + Lenvatinib
n=181 Participants
Placebo was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
Total
n=534 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
244 Participants
n=20 Participants
|
147 Participants
n=20 Participants
|
391 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
109 Participants
n=20 Participants
|
34 Participants
n=20 Participants
|
143 Participants
n=40 Participants
|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 11.23 • n=20 Participants
|
53.7 years
STANDARD_DEVIATION 11.77 • n=20 Participants
|
56.0 years
STANDARD_DEVIATION 11.52 • n=40 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=20 Participants
|
29 Participants
n=20 Participants
|
79 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
303 Participants
n=20 Participants
|
152 Participants
n=20 Participants
|
455 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
353 Participants
n=20 Participants
|
181 Participants
n=20 Participants
|
534 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
338 Participants
n=20 Participants
|
171 Participants
n=20 Participants
|
509 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
24 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
China
|
322 participants
n=20 Participants
|
166 participants
n=20 Participants
|
488 participants
n=40 Participants
|
|
Region of Enrollment
Taiwan
|
16 participants
n=20 Participants
|
4 participants
n=20 Participants
|
20 participants
n=40 Participants
|
|
Region of Enrollment
Spain
|
9 participants
n=20 Participants
|
7 participants
n=20 Participants
|
16 participants
n=40 Participants
|
|
Region of Enrollment
Poland
|
6 participants
n=20 Participants
|
4 participants
n=20 Participants
|
10 participants
n=40 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
ECOG = 0
|
148 Participants
n=20 Participants
|
77 Participants
n=20 Participants
|
225 Participants
n=40 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
ECOG = 1
|
205 Participants
n=20 Participants
|
104 Participants
n=20 Participants
|
309 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: From enrollment to end of follow-up, a median of 42.5 monthsPopulation: Analysis population consisted of all randomized participants
OS was defined as the time interval between the date of randomization to the date of death from any cause.
Outcome measures
| Measure |
Nofazinlimab + Lenvatinib
n=353 Participants
Nofazinlimab (200 mg) was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
Placebo + Lenvatinib
n=181 Participants
Placebo was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
|---|---|---|
|
Overall Survival (OS)
|
21.6 months
Interval 18.6 to 24.6
|
18.5 months
Interval 14.7 to 21.8
|
SECONDARY outcome
Timeframe: From enrollment to end of follow-up, a median of 42.5 monthsPopulation: Analysis population consisted of all randomized participants
ORR assessed by BICR was defined as the proportion of participants who achieve objective response (complete response \[CR\] or partial response \[PR\]) assessed by BICR based on RECIST v1.1.
Outcome measures
| Measure |
Nofazinlimab + Lenvatinib
n=353 Participants
Nofazinlimab (200 mg) was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
Placebo + Lenvatinib
n=181 Participants
Placebo was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
|---|---|---|
|
Objective Response Rate (ORR) Assessed by Blinded Independent Central Review Committee(BICR)
|
33.1 percentage of participants
Interval 28.3 to 38.3
|
18.8 percentage of participants
Interval 13.4 to 25.2
|
SECONDARY outcome
Timeframe: From enrollment to end of follow-up, a median of 42.5 monthsPopulation: Analysis population consisted of all randomized participants
PFS assessed by BICR was defined as the time from the date of randomization to disease progression assessed by BICR or death, whichever occurs first.
Outcome measures
| Measure |
Nofazinlimab + Lenvatinib
n=353 Participants
Nofazinlimab (200 mg) was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
Placebo + Lenvatinib
n=181 Participants
Placebo was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
|---|---|---|
|
Progression-free Survival(PFS) Assessed by Blinded Independent Central Review Committee(BICR) Based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
|
9.2 months
Interval 8.1 to 11.0
|
6.9 months
Interval 5.6 to 8.3
|
SECONDARY outcome
Timeframe: From enrollment to end of follow-up, a median of 42.5 monthsPopulation: Analysis population consisted of all randomized participants
Outcome measures
| Measure |
Nofazinlimab + Lenvatinib
n=353 Participants
Nofazinlimab (200 mg) was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
Placebo + Lenvatinib
n=181 Participants
Placebo was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
|---|---|---|
|
Progression-free Survival(PFS) Evaluated by Investigator Based on RECIST v1.1
|
9.7 months
Interval 8.4 to 11.0
|
6.9 months
Interval 5.7 to 8.3
|
SECONDARY outcome
Timeframe: From enrollment to end of follow-up, a median of 42.5 monthsPopulation: Analysis population consisted of all randomized participants
Outcome measures
| Measure |
Nofazinlimab + Lenvatinib
n=353 Participants
Nofazinlimab (200 mg) was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
Placebo + Lenvatinib
n=181 Participants
Placebo was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
|---|---|---|
|
Objective Response Rate (ORR) Evaluated by Investigators Based on RECIST v1.1
|
34.8 percentage of participants
Interval 29.9 to 40.1
|
24.3 percentage of participants
Interval 18.3 to 31.2
|
SECONDARY outcome
Timeframe: From enrollment to end of follow-up, a median of 42.5 monthsPopulation: Analysis based on the population of responders (participants that achieved complete or partial response)
Outcome measures
| Measure |
Nofazinlimab + Lenvatinib
n=117 Participants
Nofazinlimab (200 mg) was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
Placebo + Lenvatinib
n=34 Participants
Placebo was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
|---|---|---|
|
Duration of Response (DoR) Evaluated by Blinded Independent Central Review Committee(BICR) Based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
|
12.4 months
Interval 9.6 to 16.6
|
11.1 months
Interval 5.8 to 14.5
|
SECONDARY outcome
Timeframe: From enrollment to end of follow-up, a median of 42.5 monthsPopulation: Analysis based on the population of responders (participants that achieved complete or partial response)
Outcome measures
| Measure |
Nofazinlimab + Lenvatinib
n=123 Participants
Nofazinlimab (200 mg) was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
Placebo + Lenvatinib
n=44 Participants
Placebo was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
|---|---|---|
|
Duration of Response (DoR) Evaluated by Investigators Based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
|
13.8 months
Interval 10.4 to 16.1
|
11.2 months
Interval 8.4 to 14.6
|
SECONDARY outcome
Timeframe: From enrollment to end of follow-up, a median of 42.5 monthsPopulation: Analysis population consisted of all randomized participants
Outcome measures
| Measure |
Nofazinlimab + Lenvatinib
n=353 Participants
Nofazinlimab (200 mg) was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
Placebo + Lenvatinib
n=181 Participants
Placebo was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
|---|---|---|
|
Disease Control Rate (DCR) Evaluated by Blinded Independent Central Review Committee(BICR) Based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
|
80.5 percentage of participants
Interval 75.9 to 84.5
|
80.7 percentage of participants
Interval 74.1 to 86.1
|
SECONDARY outcome
Timeframe: From enrollment to end of follow-up, a median of 42.5 monthsPopulation: Analysis population consisted of all randomized participants
Outcome measures
| Measure |
Nofazinlimab + Lenvatinib
n=353 Participants
Nofazinlimab (200 mg) was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
Placebo + Lenvatinib
n=181 Participants
Placebo was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
|---|---|---|
|
Disease Control Rate (DCR) Evaluated by Investigators Based on Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
|
83.9 percentage of participants
Interval 79.6 to 87.5
|
83.4 percentage of participants
Interval 77.2 to 88.5
|
SECONDARY outcome
Timeframe: From enrollment to end of follow-up, a median of 42.5 monthsPopulation: Analysis population consisted of all randomized participants who received at least 1 dose of study intervention
Outcome measures
| Measure |
Nofazinlimab + Lenvatinib
n=352 Participants
Nofazinlimab (200 mg) was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
Placebo + Lenvatinib
n=181 Participants
Placebo was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
|---|---|---|
|
Percentage of Participants With Adverse Events
|
346 Participants
|
180 Participants
|
SECONDARY outcome
Timeframe: Peak: assessed post-dose (within 30 minutes after the end of infusion) on Cycle 4 Day 1; Trough: assessed pre-dose (within 60 minutes prior to infusion) on Cycle 4 Day 1 (cycle length = 21 days).Population: Analysis population consisted of participants who receive at least 1 dose of CS1003 for whom there is at least one available PK concentration data
Outcome measures
| Measure |
Nofazinlimab + Lenvatinib
n=352 Participants
Nofazinlimab (200 mg) was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
Placebo + Lenvatinib
Placebo was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
|---|---|---|
|
Peak and Trough Serum Concentrations of CS1003
Peak Concentrations of Nofazinlimab at Cycle 4
|
85.7 μg/mL
Standard Deviation 23.2
|
—
|
|
Peak and Trough Serum Concentrations of CS1003
Trough Concentrations of Nofazinlimab at Cycle 4
|
19.3 μg/mL
Standard Deviation 7.9
|
—
|
SECONDARY outcome
Timeframe: From enrollment to end of follow-up, a median of 42.5 monthsPopulation: Analysis population consisted of participants who receive at least 1 dose of CS1003 and have at least one reportable ADA result
Outcome measures
| Measure |
Nofazinlimab + Lenvatinib
n=352 Participants
Nofazinlimab (200 mg) was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
Placebo + Lenvatinib
Placebo was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
|---|---|---|
|
Number and Percentage of Subjects Who Develop Anti-CS1003 Antibody (ADA)
|
24 Participants
|
—
|
SECONDARY outcome
Timeframe: From enrollment to end of follow-up, a median of 42.5 monthsPopulation: Analysis population consisted of participants with both a non-missing baseline PRO assessment and at least one post-baseline PRO assessment
Outcome measures
| Measure |
Nofazinlimab + Lenvatinib
n=339 Participants
Nofazinlimab (200 mg) was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
Placebo + Lenvatinib
n=178 Participants
Placebo was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
|---|---|---|
|
Time to Deterioration (TTD), Defined as the Time From Randomization to the First Deterioration of European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Scale
Time to deterioration of physical functioning
|
21.1 months
Interval 15.8 to 29.7
|
29.7 months
Interval 18.2 to
Insufficient number of participants with events.
|
|
Time to Deterioration (TTD), Defined as the Time From Randomization to the First Deterioration of European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Scale
Time to deterioration of role functioning
|
19.6 months
Interval 15.2 to 29.7
|
23.0 months
Interval 17.8 to
Insufficient number of participants with events.
|
|
Time to Deterioration (TTD), Defined as the Time From Randomization to the First Deterioration of European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Scale
Time to deterioration of quality of life
|
17.1 months
Interval 13.0 to 23.8
|
20.5 months
Interval 11.0 to 29.7
|
Adverse Events
Nofazinlimab + Lenvatinib
Serious events: 138 serious events
Other events: 343 other events
Deaths: 253 deaths
Placebo + Lenvatinib
Serious events: 55 serious events
Other events: 180 other events
Deaths: 137 deaths
Serious adverse events
| Measure |
Nofazinlimab + Lenvatinib
n=352 participants at risk
Nofazinlimab (200 mg) was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
Placebo + Lenvatinib
n=181 participants at risk
Placebo was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.85%
3/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Blood and lymphatic system disorders
Hypersplenism
|
0.00%
0/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.00%
0/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
1.1%
2/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Cardiac disorders
Angina pectoris
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Cardiac disorders
Arrhythmia
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Cardiac disorders
Coronary artery disease
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Cardiac disorders
Myocardial infarction
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
1.1%
2/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Cardiac disorders
Ventricular tachycardia
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Endocrine disorders
Immune-mediated endocrinopathy
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.85%
3/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.85%
3/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Anal fistula
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Ascites
|
1.1%
4/352 • From enrollment to end of follow-up, a median of 42.5 months
|
2.2%
4/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Colitis
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
1.1%
2/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.57%
2/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Femoral hernia strangulated
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Gastritis
|
0.57%
2/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.85%
3/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Mesenteric artery stenosis
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Nausea
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.57%
2/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.57%
2/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.7%
6/352 • From enrollment to end of follow-up, a median of 42.5 months
|
3.3%
6/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Vomiting
|
0.57%
2/352 • From enrollment to end of follow-up, a median of 42.5 months
|
1.1%
2/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
General disorders
Asthenia
|
1.1%
4/352 • From enrollment to end of follow-up, a median of 42.5 months
|
1.7%
3/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
General disorders
Death
|
2.8%
10/352 • From enrollment to end of follow-up, a median of 42.5 months
|
1.7%
3/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
General disorders
Fatigue
|
0.85%
3/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
General disorders
Oedema peripheral
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
General disorders
Pyrexia
|
0.85%
3/352 • From enrollment to end of follow-up, a median of 42.5 months
|
1.1%
2/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
General disorders
Sudden death
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.57%
2/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Hepatobiliary disorders
Hepatic failure
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
2.0%
7/352 • From enrollment to end of follow-up, a median of 42.5 months
|
2.8%
5/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Hepatobiliary disorders
Hepatic pain
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/352 • From enrollment to end of follow-up, a median of 42.5 months
|
1.1%
2/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Anorectal infection
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Appendicitis
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Bronchitis
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
COVID-19
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
COVID-19 pneumonia
|
0.85%
3/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Cellulitis
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Clostridium difficile colitis
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Escherichia sepsis
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Febrile infection
|
0.00%
0/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Focal peritonitis
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Hepatitis B reactivation
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Hepatobiliary infection
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Herpes zoster
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Infected dermal cyst
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Infection
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Influenza
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Parapharyngeal space infection
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Peritonitis
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Pneumonia
|
2.3%
8/352 • From enrollment to end of follow-up, a median of 42.5 months
|
2.2%
4/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Respiratory tract infection
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Septic shock
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Skin bacterial infection
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Tuberculosis
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/352 • From enrollment to end of follow-up, a median of 42.5 months
|
1.1%
2/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Urinary tract infection
|
1.1%
4/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Injury, poisoning and procedural complications
Fracture
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
Alanine aminotransferase increased
|
2.0%
7/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
Aspartate aminotransferase increased
|
3.4%
12/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
Bilirubin conjugated increased
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
Blood bilirubin increased
|
2.0%
7/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
Blood creatine phosphokinase increased
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
C-reactive protein increased
|
0.00%
0/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
Neutrophil count decreased
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
Platelet count decreased
|
1.4%
5/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
Troponin I increased
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
Troponin T increased
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
White blood cell count decreased
|
0.57%
2/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.57%
2/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.57%
2/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver carcinoma ruptured
|
0.57%
2/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sinonasal papilloma
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Nervous system disorders
Cerebral atrophy
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.85%
3/352 • From enrollment to end of follow-up, a median of 42.5 months
|
1.1%
2/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Nervous system disorders
Cerebral infarction
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Nervous system disorders
Cerebral ischaemia
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.57%
2/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Nervous system disorders
Hepatic encephalopathy
|
2.8%
10/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Nervous system disorders
Hypoaesthesia
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Nervous system disorders
Immune-mediated neuropathy
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Nervous system disorders
Lacunar infarction
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Nervous system disorders
Myasthenic syndrome
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.57%
2/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Renal and urinary disorders
Proteinuria
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Renal and urinary disorders
Renal failure
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
1.1%
2/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.85%
3/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.57%
2/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal erosion
|
0.00%
0/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Skin and subcutaneous tissue disorders
Pemphigus
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.55%
1/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Vascular disorders
Artery dissection
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Vascular disorders
Embolism arterial
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Vascular disorders
Haematoma
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Vascular disorders
Hypertension
|
0.28%
1/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Vascular disorders
Hypotension
|
0.57%
2/352 • From enrollment to end of follow-up, a median of 42.5 months
|
0.00%
0/181 • From enrollment to end of follow-up, a median of 42.5 months
|
Other adverse events
| Measure |
Nofazinlimab + Lenvatinib
n=352 participants at risk
Nofazinlimab (200 mg) was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
Placebo + Lenvatinib
n=181 participants at risk
Placebo was administered by i.v. infusion every three weeks (Q3W). Lenvatinib was orally administered at 12 mg (if the participant's weight ≥ 60 kg) or 8 mg (if the participant's weight \< 60 kg), once daily. All participants received assigned treatment until progression of disease, unacceptable toxicity, participant withdraws informed consent, death, other causes specified in the protocol or the end of study, whichever occurs first.
|
|---|---|---|
|
General disorders
Oedema peripheral
|
6.0%
21/352 • From enrollment to end of follow-up, a median of 42.5 months
|
3.9%
7/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
General disorders
Pyrexia
|
11.6%
41/352 • From enrollment to end of follow-up, a median of 42.5 months
|
7.7%
14/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Blood and lymphatic system disorders
Anaemia
|
20.7%
73/352 • From enrollment to end of follow-up, a median of 42.5 months
|
16.6%
30/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Endocrine disorders
Hyperthyroidism
|
11.4%
40/352 • From enrollment to end of follow-up, a median of 42.5 months
|
2.8%
5/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Endocrine disorders
Hypothyroidism
|
43.2%
152/352 • From enrollment to end of follow-up, a median of 42.5 months
|
39.2%
71/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
44/352 • From enrollment to end of follow-up, a median of 42.5 months
|
10.5%
19/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Abdominal pain
|
13.9%
49/352 • From enrollment to end of follow-up, a median of 42.5 months
|
15.5%
28/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.7%
27/352 • From enrollment to end of follow-up, a median of 42.5 months
|
6.6%
12/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Constipation
|
7.1%
25/352 • From enrollment to end of follow-up, a median of 42.5 months
|
6.6%
12/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Diarrhoea
|
33.5%
118/352 • From enrollment to end of follow-up, a median of 42.5 months
|
32.6%
59/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Gingival bleeding
|
3.1%
11/352 • From enrollment to end of follow-up, a median of 42.5 months
|
5.5%
10/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Mouth ulceration
|
5.1%
18/352 • From enrollment to end of follow-up, a median of 42.5 months
|
2.8%
5/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Nausea
|
9.4%
33/352 • From enrollment to end of follow-up, a median of 42.5 months
|
7.7%
14/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Toothache
|
6.2%
22/352 • From enrollment to end of follow-up, a median of 42.5 months
|
4.4%
8/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Gastrointestinal disorders
Vomiting
|
10.2%
36/352 • From enrollment to end of follow-up, a median of 42.5 months
|
9.4%
17/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
General disorders
Asthenia
|
8.8%
31/352 • From enrollment to end of follow-up, a median of 42.5 months
|
9.4%
17/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
General disorders
Fatigue
|
12.5%
44/352 • From enrollment to end of follow-up, a median of 42.5 months
|
12.2%
22/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
7.1%
25/352 • From enrollment to end of follow-up, a median of 42.5 months
|
3.3%
6/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
COVID-19
|
6.0%
21/352 • From enrollment to end of follow-up, a median of 42.5 months
|
2.8%
5/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
27/352 • From enrollment to end of follow-up, a median of 42.5 months
|
5.5%
10/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Infections and infestations
Urinary tract infection
|
6.8%
24/352 • From enrollment to end of follow-up, a median of 42.5 months
|
11.6%
21/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
Alanine aminotransferase increased
|
30.1%
106/352 • From enrollment to end of follow-up, a median of 42.5 months
|
30.4%
55/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
Aspartate aminotransferase increased
|
33.0%
116/352 • From enrollment to end of follow-up, a median of 42.5 months
|
36.5%
66/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
Bilirubin conjugated increased
|
5.1%
18/352 • From enrollment to end of follow-up, a median of 42.5 months
|
3.3%
6/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
Blood alkaline phosphatase increased
|
12.2%
43/352 • From enrollment to end of follow-up, a median of 42.5 months
|
8.8%
16/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
Blood bilirubin increased
|
31.0%
109/352 • From enrollment to end of follow-up, a median of 42.5 months
|
34.3%
62/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
Blood creatine phosphokinase increased
|
7.1%
25/352 • From enrollment to end of follow-up, a median of 42.5 months
|
2.8%
5/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
Blood creatinine increased
|
6.5%
23/352 • From enrollment to end of follow-up, a median of 42.5 months
|
1.7%
3/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.8%
24/352 • From enrollment to end of follow-up, a median of 42.5 months
|
3.9%
7/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
Blood thyroid stimulating hormone increased
|
9.1%
32/352 • From enrollment to end of follow-up, a median of 42.5 months
|
18.8%
34/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
14.5%
51/352 • From enrollment to end of follow-up, a median of 42.5 months
|
13.3%
24/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
Lymphocyte count decreased
|
8.8%
31/352 • From enrollment to end of follow-up, a median of 42.5 months
|
6.6%
12/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
Neutrophil count decreased
|
23.6%
83/352 • From enrollment to end of follow-up, a median of 42.5 months
|
27.1%
49/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
Platelet count decreased
|
48.9%
172/352 • From enrollment to end of follow-up, a median of 42.5 months
|
49.2%
89/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
SARS-CoV-2 test positive
|
7.7%
27/352 • From enrollment to end of follow-up, a median of 42.5 months
|
2.2%
4/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
Weight decreased
|
37.8%
133/352 • From enrollment to end of follow-up, a median of 42.5 months
|
28.2%
51/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Investigations
White blood cell count decreased
|
29.3%
103/352 • From enrollment to end of follow-up, a median of 42.5 months
|
28.7%
52/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
24.7%
87/352 • From enrollment to end of follow-up, a median of 42.5 months
|
19.9%
36/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.0%
21/352 • From enrollment to end of follow-up, a median of 42.5 months
|
3.9%
7/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
5.7%
20/352 • From enrollment to end of follow-up, a median of 42.5 months
|
5.5%
10/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
9.9%
35/352 • From enrollment to end of follow-up, a median of 42.5 months
|
6.1%
11/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
27.3%
96/352 • From enrollment to end of follow-up, a median of 42.5 months
|
22.7%
41/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.8%
52/352 • From enrollment to end of follow-up, a median of 42.5 months
|
8.8%
16/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.0%
28/352 • From enrollment to end of follow-up, a median of 42.5 months
|
7.2%
13/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
8.0%
28/352 • From enrollment to end of follow-up, a median of 42.5 months
|
2.2%
4/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.2%
43/352 • From enrollment to end of follow-up, a median of 42.5 months
|
11.6%
21/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.6%
9/352 • From enrollment to end of follow-up, a median of 42.5 months
|
5.5%
10/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Psychiatric disorders
Insomnia
|
7.1%
25/352 • From enrollment to end of follow-up, a median of 42.5 months
|
5.5%
10/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Renal and urinary disorders
Haematuria
|
11.6%
41/352 • From enrollment to end of follow-up, a median of 42.5 months
|
10.5%
19/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Renal and urinary disorders
Proteinuria
|
57.7%
203/352 • From enrollment to end of follow-up, a median of 42.5 months
|
56.9%
103/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
28/352 • From enrollment to end of follow-up, a median of 42.5 months
|
5.5%
10/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.4%
19/352 • From enrollment to end of follow-up, a median of 42.5 months
|
5.0%
9/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
25.3%
89/352 • From enrollment to end of follow-up, a median of 42.5 months
|
22.1%
40/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.5%
23/352 • From enrollment to end of follow-up, a median of 42.5 months
|
4.4%
8/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.2%
43/352 • From enrollment to end of follow-up, a median of 42.5 months
|
7.2%
13/181 • From enrollment to end of follow-up, a median of 42.5 months
|
|
Vascular disorders
Hypertension
|
40.3%
142/352 • From enrollment to end of follow-up, a median of 42.5 months
|
39.8%
72/181 • From enrollment to end of follow-up, a median of 42.5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If the sponsor has not published trial results within 18 months since trial completion, the PI is allowed to publish data collected at the corresponding site. The PI should provide draft publication to the sponsor to review prior to distribution to any external parties; the sponsor should provide review comments to the PI within 60 calendar days since receipt of draft publication; the sponsor also has rights to postpone publication for up to 6 months based on reasonable grounds.
- Publication restrictions are in place
Restriction type: OTHER