Trial Outcomes & Findings for A Study of Unesbulin in Participants With Advanced Leiomyosarcoma (LMS) (NCT NCT05269355)
NCT ID: NCT05269355
Last Updated: 2025-06-13
Results Overview
PFS was defined as the time from randomization to the documented disease progression or death due to any cause, whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions was also considered progression.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
359 participants
Primary outcome timeframe
Up to approximately 2 years
Results posted on
2025-06-13
Participant Flow
Participants were randomized 2:1 to 1 of the following treatment groups: 1. Unesbulin and Dacarbazine or 2. Placebo and Dacarbazine.
Participant milestones
| Measure |
Unesbulin and Dacarbazine
Participants received unesbulin 300 milligrams (mg) tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/square meter (m\^2) intravenously (IV) once every 21 days. Treatment was continued for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
|
Placebo and Dacarbazine
Participants received placebo matching to unesbulin tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/m\^2 IV once every 21 days. Treatment was continued for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
|
|---|---|---|
|
Overall Study
STARTED
|
239
|
120
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
238
|
120
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
239
|
120
|
Reasons for withdrawal
| Measure |
Unesbulin and Dacarbazine
Participants received unesbulin 300 milligrams (mg) tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/square meter (m\^2) intravenously (IV) once every 21 days. Treatment was continued for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
|
Placebo and Dacarbazine
Participants received placebo matching to unesbulin tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/m\^2 IV once every 21 days. Treatment was continued for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
|
|---|---|---|
|
Overall Study
Progressive Disease
|
104
|
68
|
|
Overall Study
Study Terminated by Sponsor
|
87
|
29
|
|
Overall Study
Adverse Event
|
15
|
8
|
|
Overall Study
Withdrawal by Subject
|
18
|
5
|
|
Overall Study
Physician Decision
|
6
|
4
|
|
Overall Study
Death
|
3
|
5
|
|
Overall Study
Other Than Specified
|
5
|
1
|
|
Overall Study
Randomized But Not Treated
|
1
|
0
|
Baseline Characteristics
A Study of Unesbulin in Participants With Advanced Leiomyosarcoma (LMS)
Baseline characteristics by cohort
| Measure |
Unesbulin and Dacarbazine
n=238 Participants
Participants received unesbulin 300 mg tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/m\^2 IV once every 21 days. Treatment was continued for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
|
Placebo and Dacarbazine
n=120 Participants
Participants received placebo matching to unesbulin tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/m\^2 IV once every 21 days. Treatment was continued for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
|
Total
n=358 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.4 years
STANDARD_DEVIATION 10.98 • n=93 Participants
|
58.6 years
STANDARD_DEVIATION 11.04 • n=4 Participants
|
57.8 years
STANDARD_DEVIATION 11.00 • n=27 Participants
|
|
Sex: Female, Male
Female
|
187 Participants
n=93 Participants
|
93 Participants
n=4 Participants
|
280 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
78 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
36 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
170 Participants
n=93 Participants
|
87 Participants
n=4 Participants
|
257 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
32 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
17 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian/Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Black/African American
|
20 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian/Other Pacific Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · White/Caucasian
|
157 Participants
n=93 Participants
|
92 Participants
n=4 Participants
|
249 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
38 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Missing
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Multiple
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 2 yearsPopulation: The modified intent-to-treat (mITT) set included randomized participants with 1 to 3 prior lines of therapy.
PFS was defined as the time from randomization to the documented disease progression or death due to any cause, whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions was also considered progression.
Outcome measures
| Measure |
Unesbulin and Dacarbazine
n=209 Participants
Participants received unesbulin 300 mg tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/m\^2 IV once every 21 days. Treatment was continued for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
|
Placebo and Dacarbazine
n=105 Participants
Participants received placebo matching to unesbulin tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/m\^2 IV once every 21 days. Treatment was continued for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
|
|---|---|---|
|
Progression Free Survival (PFS) Per Independent Central Review Using Response Evaluation Criteria in Solid Tumors (RECIST) V1.1
|
3.6 months
Interval 2.8 to 5.5
|
2.6 months
Interval 1.5 to 3.0
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: The mITT set included randomized participants with 1 to 3 prior lines of therapy.
Overall survival was defined as the time in months from the randomization date to the date of death from any cause or date last known alive for those who did not die.
Outcome measures
| Measure |
Unesbulin and Dacarbazine
n=209 Participants
Participants received unesbulin 300 mg tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/m\^2 IV once every 21 days. Treatment was continued for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
|
Placebo and Dacarbazine
n=105 Participants
Participants received placebo matching to unesbulin tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/m\^2 IV once every 21 days. Treatment was continued for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
|
|---|---|---|
|
Overall Survival
|
NA months
Interval 10.4 to
Due to limited number of participants with an event, median and upper limit of 95% confidence interval (CI) could not be calculated.
|
NA months
Interval 11.0 to
Due to limited number of participants with an event, median and upper limit of 95% CI could not be calculated.
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: The mITT set included randomized participants with 1 to 3 prior lines of therapy.
ORR was defined as percentage of participants who achieved a confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Unesbulin and Dacarbazine
n=209 Participants
Participants received unesbulin 300 mg tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/m\^2 IV once every 21 days. Treatment was continued for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
|
Placebo and Dacarbazine
n=105 Participants
Participants received placebo matching to unesbulin tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/m\^2 IV once every 21 days. Treatment was continued for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
|
|---|---|---|
|
Objective Response Rate (ORR) Per Independent Central Review Using RECIST V1.1
|
8.1 percentage of participants
Interval 4.7 to 12.8
|
2.1 percentage of participants
Interval 0.3 to 7.3
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: The mITT set included randomized participants with 1 to 3 prior lines of therapy.
DCR was defined as percentage of participants who achieved a confirmed BOR of CR, PR, or at least 3 months of stable disease (SD). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Unesbulin and Dacarbazine
n=209 Participants
Participants received unesbulin 300 mg tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/m\^2 IV once every 21 days. Treatment was continued for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
|
Placebo and Dacarbazine
n=105 Participants
Participants received placebo matching to unesbulin tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/m\^2 IV once every 21 days. Treatment was continued for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
|
|---|---|---|
|
Disease Control Rate (DCR) Per Independent Central Review Using RECIST V1.1
|
36.4 percentage of participants
Interval 29.7 to 43.5
|
27.1 percentage of participants
Interval 18.5 to 37.1
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: The mITT set included randomized participants with 1 to 3 prior lines of therapy.
Duration of response was defined as the time from the date of first confirmed response of CR or PR to the date of the first documented disease progression or death due to any cause, whichever occurred first. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
Outcome measures
| Measure |
Unesbulin and Dacarbazine
n=209 Participants
Participants received unesbulin 300 mg tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/m\^2 IV once every 21 days. Treatment was continued for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
|
Placebo and Dacarbazine
n=105 Participants
Participants received placebo matching to unesbulin tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/m\^2 IV once every 21 days. Treatment was continued for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
|
|---|---|---|
|
Duration of Response Per Independent Central Review Using RECIST V1.1
|
6.87 months
Due to limited number of participants with an event, upper and lower limit of 95% CI could not be calculated.
|
NA months
Due to limited number of participants with an event, median and upper and lower limit of 95% CI could not be calculated.
|
SECONDARY outcome
Timeframe: From first dose of study drug up to approximately 2 yearsPopulation: The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A TEAE was defined as an AE that had an onset date on or after the first dose of study drug until 30 days after last dose or occurred prior to first dose of study drug and worsened in severity after first dose of study drug. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Outcome measures
| Measure |
Unesbulin and Dacarbazine
n=238 Participants
Participants received unesbulin 300 mg tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/m\^2 IV once every 21 days. Treatment was continued for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
|
Placebo and Dacarbazine
n=120 Participants
Participants received placebo matching to unesbulin tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/m\^2 IV once every 21 days. Treatment was continued for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
236 Participants
|
112 Participants
|
Adverse Events
Unesbulin and Dacarbazine
Serious events: 81 serious events
Other events: 234 other events
Deaths: 49 deaths
Placebo and Dacarbazine
Serious events: 43 serious events
Other events: 112 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Unesbulin and Dacarbazine
n=238 participants at risk
Participants received unesbulin 300 mg tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/m\^2 IV once every 21 days. Treatment was continued for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
|
Placebo and Dacarbazine
n=120 participants at risk
Participants received placebo matching to unesbulin tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/m\^2 IV once every 21 days. Treatment was continued for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.1%
5/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
2.5%
3/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Blood and lymphatic system disorders
Bicytopenia
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.4%
8/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Blood and lymphatic system disorders
Haematotoxicity
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.7%
4/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
1.7%
2/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.3%
3/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.5%
6/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
1.7%
2/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Cardiac disorders
Angina pectoris
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Cardiac disorders
Atrial fibrillation
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Cardiac disorders
Atrial tachycardia
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Cardiac disorders
Myocardial infarction
|
0.84%
2/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Congenital, familial and genetic disorders
Aplasia
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
3/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
1.7%
2/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Gastrointestinal disorders
Ascites
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Gastrointestinal disorders
Constipation
|
0.84%
2/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.84%
2/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Gastrointestinal disorders
Nausea
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.84%
2/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Gastrointestinal disorders
Vomiting
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
General disorders
Asthenia
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
General disorders
Disease progression
|
1.3%
3/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
4.2%
5/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
General disorders
Fatigue
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
General disorders
General physical health deterioration
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
General disorders
Malaise
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
General disorders
Non-cardiac chest pain
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
General disorders
Pain
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
General disorders
Pyrexia
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
4.2%
5/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
General disorders
Systemic inflammatory response syndrome
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Hepatobiliary disorders
Subcapsular hepatic haematoma
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Infections and infestations
COVID-19
|
2.1%
5/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Infections and infestations
Cellulitis
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Infections and infestations
Cystitis
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Infections and infestations
Device related sepsis
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Infections and infestations
Pertussis
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Infections and infestations
Pneumonia
|
1.3%
3/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Infections and infestations
Pyelonephritis
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Infections and infestations
Sepsis
|
1.7%
4/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
2.5%
3/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Infections and infestations
Septic shock
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Infections and infestations
Soft tissue infection
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Infections and infestations
Spinal cord infection
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Infections and infestations
Urinary tract infection
|
0.84%
2/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Infections and infestations
Urosepsis
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Infections and infestations
Vascular device infection
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.84%
2/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Injury, poisoning and procedural complications
Fall
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Investigations
Blood bilirubin increased
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Investigations
Neutrophil count decreased
|
0.84%
2/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Investigations
Platelet count decreased
|
2.1%
5/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Investigations
Transaminases increased
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Investigations
White blood cell count decreased
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.84%
2/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.84%
2/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
1.3%
3/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Nervous system disorders
Central nervous system lesion
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Nervous system disorders
Headache
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Nervous system disorders
Seizure
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Nervous system disorders
Spinal cord compression
|
0.84%
2/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Product Issues
Device occlusion
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Psychiatric disorders
Suicidal ideation
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.84%
2/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.53%
1/187 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/93 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.84%
2/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
5.0%
6/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.84%
2/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.00%
0/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Vascular disorders
Deep vein thrombosis
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
0.83%
1/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Vascular disorders
Hypotension
|
0.42%
1/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
1.7%
2/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
Other adverse events
| Measure |
Unesbulin and Dacarbazine
n=238 participants at risk
Participants received unesbulin 300 mg tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/m\^2 IV once every 21 days. Treatment was continued for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
|
Placebo and Dacarbazine
n=120 participants at risk
Participants received placebo matching to unesbulin tablets administered orally twice weekly in each 3-week treatment cycle in combination with dacarbazine 1000 mg/m\^2 IV once every 21 days. Treatment was continued for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
43.3%
103/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
29.2%
35/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.3%
15/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
5.8%
7/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Blood and lymphatic system disorders
Neutropenia
|
37.0%
88/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
19.2%
23/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
31.5%
75/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
22.5%
27/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Gastrointestinal disorders
Abdominal pain
|
17.6%
42/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
9.2%
11/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.5%
13/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
5.0%
6/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Gastrointestinal disorders
Constipation
|
21.0%
50/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
15.8%
19/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Gastrointestinal disorders
Diarrhoea
|
55.0%
131/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
22.5%
27/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Gastrointestinal disorders
Nausea
|
48.3%
115/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
36.7%
44/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Gastrointestinal disorders
Vomiting
|
18.1%
43/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
14.2%
17/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
General disorders
Asthenia
|
11.3%
27/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
10.0%
12/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
General disorders
Fatigue
|
39.1%
93/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
36.7%
44/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
General disorders
Non-cardiac chest pain
|
6.3%
15/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
4.2%
5/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
General disorders
Oedema peripheral
|
8.4%
20/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
10.0%
12/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
General disorders
Pyrexia
|
6.3%
15/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
7.5%
9/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Infections and infestations
COVID-19
|
5.5%
13/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
7.5%
9/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Infections and infestations
Urinary tract infection
|
5.9%
14/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
6.7%
8/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Investigations
Alanine aminotransferase increased
|
7.6%
18/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
8.3%
10/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Investigations
Aspartate aminotransferase increased
|
8.4%
20/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
6.7%
8/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Investigations
Blood creatinine increased
|
5.5%
13/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
4.2%
5/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Investigations
Neutrophil count decreased
|
25.2%
60/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
10.8%
13/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Investigations
Platelet count decreased
|
21.4%
51/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
14.2%
17/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Investigations
White blood cell count decreased
|
15.1%
36/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
7.5%
9/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.5%
37/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
11.7%
14/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.6%
11/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
5.8%
7/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.4%
20/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
10.0%
12/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.2%
22/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
10.8%
13/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.0%
19/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
4.2%
5/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Nervous system disorders
Dizziness
|
13.4%
32/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
8.3%
10/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Nervous system disorders
Dysgeusia
|
7.1%
17/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
1.7%
2/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Nervous system disorders
Headache
|
12.2%
29/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
11.7%
14/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Nervous system disorders
Neuropathy peripheral
|
6.3%
15/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
3.3%
4/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Psychiatric disorders
Insomnia
|
5.9%
14/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
3.3%
4/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.2%
29/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
8.3%
10/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.9%
26/238 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
19.2%
23/120 • From first dose of study drug up to approximately 2 years
The safety analysis set included all participants who received at least 1 dose of study drug (unesbulin/placebo or dacarbazine).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor can review results and/or communications prior to public release and can embargo communications regarding trial results for a period that is up to 180 days from the time submitted to the Sponsor for review. The Sponsor may consult with the PI to require changes to the communication or extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER