Trial Outcomes & Findings for Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma (NCT NCT01327885)
NCT ID: NCT01327885
Last Updated: 2023-06-22
Results Overview
OS was defined as the time in months from the date of treatment start until death, regardless of cause. In the absence of confirmation of death, participants were censored either at the date that participant was last known to be alive or the date of study cut-off, whichever was earlier. Participants who died on the date of randomization had a survival time of 0.5 day. Allocation of randomization numbers were performed based upon the following stratification factors: (a) Histology (adipocytic \[ADI\] or leiomyosarcoma \[LMS\]), (b) Region (Region 1: USA and Canada; or Region 2: Western Europe, Australia, Israel; or Region 3: Eastern Europe, Latin America, and Asia), and (c) Number of prior regimens for advanced soft tissue sarcoma (STS) (2 or greater than \[\>\] 2 prior regimens).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
452 participants
Primary outcome timeframe
From date of treatment start until date of death from any cause, up to 5 years 5 months
Results posted on
2023-06-22
Participant Flow
Participant milestones
| Measure |
Arm A: Eribulin Mesylate
Eribulin mesylate at a dose of 1.4 milligram per square meter (mg/m\^2) was administered intravenously (IV) as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
|
Arm B: Dacarbazine
Dacarbazine at a dose of 850 mg/m\^2, 1000 mg/m\^2, or 1200 mg/m\^2 (as selected by the Principal Investigator \[PI\] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
228
|
224
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
228
|
224
|
Reasons for withdrawal
| Measure |
Arm A: Eribulin Mesylate
Eribulin mesylate at a dose of 1.4 milligram per square meter (mg/m\^2) was administered intravenously (IV) as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
|
Arm B: Dacarbazine
Dacarbazine at a dose of 850 mg/m\^2, 1000 mg/m\^2, or 1200 mg/m\^2 (as selected by the Principal Investigator \[PI\] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
|
|---|---|---|
|
Overall Study
Disease progression-according to RECIST
|
173
|
165
|
|
Overall Study
Clinical progression
|
24
|
27
|
|
Overall Study
Adverse Event
|
14
|
10
|
|
Overall Study
Subject choice
|
5
|
10
|
|
Overall Study
Other
|
8
|
6
|
|
Overall Study
Withdrawal of consent from study
|
3
|
4
|
|
Overall Study
Not treated
|
1
|
1
|
|
Overall Study
Administrative decision
|
0
|
1
|
Baseline Characteristics
Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma
Baseline characteristics by cohort
| Measure |
Arm A: Eribulin Mesylate
n=228 Participants
Eribulin mesylate at a dose of 1.4 mg/m\^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
|
Arm B: Dacarbazine
n=224 Participants
Dacarbazine at a dose of 850 mg/m\^2, 1000 mg/m\^2, or 1200 mg/m\^2 (as selected by the Principal Investigator \[PI\] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
|
Total
n=452 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.6 Years
STANDARD_DEVIATION 11.01 • n=5 Participants
|
55.7 Years
STANDARD_DEVIATION 10.35 • n=7 Participants
|
55.7 Years
STANDARD_DEVIATION 10.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
161 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
303 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of treatment start until date of death from any cause, up to 5 years 5 monthsPopulation: Full analysis set (FAS) (Intent-to-Treat (ITT) analysis set) included all participants who were randomized.
OS was defined as the time in months from the date of treatment start until death, regardless of cause. In the absence of confirmation of death, participants were censored either at the date that participant was last known to be alive or the date of study cut-off, whichever was earlier. Participants who died on the date of randomization had a survival time of 0.5 day. Allocation of randomization numbers were performed based upon the following stratification factors: (a) Histology (adipocytic \[ADI\] or leiomyosarcoma \[LMS\]), (b) Region (Region 1: USA and Canada; or Region 2: Western Europe, Australia, Israel; or Region 3: Eastern Europe, Latin America, and Asia), and (c) Number of prior regimens for advanced soft tissue sarcoma (STS) (2 or greater than \[\>\] 2 prior regimens).
Outcome measures
| Measure |
Arm A: Eribulin Mesylate
n=228 Participants
Eribulin mesylate at a dose of 1.4 mg/m\^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
|
Arm B: Dacarbazine
n=224 Participants
Dacarbazine at a dose of 850 mg/m\^2, 1000 mg/m\^2, or 1200 mg/m\^2 (as selected by the Principal Investigator \[PI\] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
|
|---|---|---|
|
Overall Survival (OS)
|
13.5 Months
Interval 10.9 to 15.6
|
11.5 Months
Interval 9.6 to 13.0
|
SECONDARY outcome
Timeframe: Randomization (day 1) to the date of first documentation of disease progression, or date of death (whichever occurred first), up to 5 years 5 monthsPopulation: FAS (ITT analysis set) included all participants who were randomized.
PFS was defined as the time from the date of randomization to the date of first documentation of disease progression, or date of death (whichever occurred first). The date of disease progression was defined as the date of radiologic disease progression as assessed by the investigator or designee based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Participants who did not have an event (i.e., participants who were lost to follow-up or who did not progress or die at the date of data cut-off), were censored. Participants who discontinued study treatment without disease progression were censored on the date of their last radiological assessment (scan date).
Outcome measures
| Measure |
Arm A: Eribulin Mesylate
n=228 Participants
Eribulin mesylate at a dose of 1.4 mg/m\^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
|
Arm B: Dacarbazine
n=224 Participants
Dacarbazine at a dose of 850 mg/m\^2, 1000 mg/m\^2, or 1200 mg/m\^2 (as selected by the Principal Investigator \[PI\] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
2.6 Months
Interval 1.9 to 2.8
|
2.6 Months
Interval 1.8 to 2.7
|
SECONDARY outcome
Timeframe: From date of randomization start until Week 12Population: FAS (ITT analysis set) included all participants who were randomized.
The PFR12wks was defined as the percentage of participants who were still alive without disease progression at 12 weeks from the date of randomization. Tumor assessment by the investigator or designee was based on RECIST criteria 1.1.
Outcome measures
| Measure |
Arm A: Eribulin Mesylate
n=228 Participants
Eribulin mesylate at a dose of 1.4 mg/m\^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
|
Arm B: Dacarbazine
n=224 Participants
Dacarbazine at a dose of 850 mg/m\^2, 1000 mg/m\^2, or 1200 mg/m\^2 (as selected by the Principal Investigator \[PI\] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
|
|---|---|---|
|
Progression-Free Rate at 12 Weeks (PFR12wks)
|
33.3 Percentage of participants
Interval 27.2 to 39.9
|
28.6 Percentage of participants
Interval 22.8 to 35.0
|
SECONDARY outcome
Timeframe: From date of treatment start (Day 1) until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, up to 5 years 5 monthsPopulation: FAS (ITT analysis set) included all participants who were randomized.
CBR was defined as the percentage of participants who have best overall response (BOR) of complete response (CR), or partial response (PR), or duration of stable disease (dSD) greater than or equal to 11 weeks, between Arm A and Arm B. CBR was estimated by treatment arm based on the tumor response evaluation performed by the PI or designee according to RECIST 1.1. CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter.
Outcome measures
| Measure |
Arm A: Eribulin Mesylate
n=228 Participants
Eribulin mesylate at a dose of 1.4 mg/m\^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
|
Arm B: Dacarbazine
n=224 Participants
Dacarbazine at a dose of 850 mg/m\^2, 1000 mg/m\^2, or 1200 mg/m\^2 (as selected by the Principal Investigator \[PI\] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
|
|---|---|---|
|
Clinical Benefit Rate (CBR)
|
46.1 Percentage of participants
Interval 39.5 to 52.8
|
47.8 Percentage of participants
Interval 41.1 to 54.5
|
Adverse Events
Arm A: Eribulin Mesylate
Serious events: 76 serious events
Other events: 224 other events
Deaths: 198 deaths
Arm B: Dacarbazine
Serious events: 71 serious events
Other events: 218 other events
Deaths: 206 deaths
Serious adverse events
| Measure |
Arm A: Eribulin Mesylate
n=228 participants at risk
Eribulin mesylate at a dose of 1.4 mg/m\^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
|
Arm B: Dacarbazine
n=224 participants at risk
Dacarbazine at a dose of 850 mg/m\^2, 1000 mg/m\^2, or 1200 mg/m\^2 (as selected by the Principal Investigator \[PI\] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
4.8%
11/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
4.5%
10/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Blood and lymphatic system disorders
Anaemia
|
2.2%
5/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
4.0%
9/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.3%
3/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
1.3%
3/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.88%
2/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.89%
2/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
1.3%
3/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
5.8%
13/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Cardiac disorders
Pericardial effusion
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
4/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
1.8%
4/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.8%
4/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
2.2%
5/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.88%
2/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.89%
2/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.88%
2/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
1.3%
3/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Constipation
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Ileus
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Oesophagitis
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Subileus
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Duodenal fistula
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
General disorders
Pyrexia
|
4.4%
10/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
1.8%
4/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
General disorders
Asthenia
|
1.3%
3/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
General disorders
General physical health deterioration
|
0.88%
2/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
General disorders
Fatigue
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.88%
2/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Immune system disorders
Hypersensitivity
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Infections and infestations
Urinary tract infection
|
1.8%
4/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Infections and infestations
Pneumonia
|
1.3%
3/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.89%
2/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Infections and infestations
Lung infection
|
0.88%
2/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Infections and infestations
Peritonitis bacterial
|
0.88%
2/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Infections and infestations
Arthritis bacterial
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Infections and infestations
Bronchopneumonia
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Infections and infestations
Catheter site infection
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Infections and infestations
Device related infection
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Infections and infestations
Lower respiratory tract infection fungal
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Infections and infestations
Neutropenic sepsis
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Infections and infestations
Peritonitis
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Infections and infestations
Pyelonephritis
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Infections and infestations
Septic shock
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Infections and infestations
Serratia bacteraemia
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Infections and infestations
Staphylococcal infection
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Infections and infestations
Erysipelas
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Investigations
Alanine aminotransferase increased
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Investigations
Electrocardiogram QT prolonged
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Investigations
International normalised ratio increased
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Investigations
Neutrophil count decreased
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Investigations
White blood cell count decreased
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.89%
2/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.88%
2/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.88%
2/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.88%
2/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to neck
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myxoid liposarcoma
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.89%
2/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Nervous system disorders
Convulsion
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Nervous system disorders
Monoplegia
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Nervous system disorders
Spinal cord compression
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Renal and urinary disorders
Renal failure acute
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.8%
4/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.8%
4/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.89%
2/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.88%
2/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
1.8%
4/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.89%
2/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Vascular disorders
Superior vena cava syndrome
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Vascular disorders
Vena cava thrombosis
|
0.44%
1/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.00%
0/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
1.3%
3/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.89%
2/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
Other adverse events
| Measure |
Arm A: Eribulin Mesylate
n=228 participants at risk
Eribulin mesylate at a dose of 1.4 mg/m\^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
|
Arm B: Dacarbazine
n=224 participants at risk
Dacarbazine at a dose of 850 mg/m\^2, 1000 mg/m\^2, or 1200 mg/m\^2 (as selected by the Principal Investigator \[PI\] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
41.7%
95/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
22.8%
51/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Blood and lymphatic system disorders
Anaemia
|
28.9%
66/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
30.4%
68/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.7%
13/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
26.8%
60/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
15.8%
36/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
9.8%
22/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Eye disorders
Lacrimation increased
|
7.9%
18/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
0.45%
1/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Nausea
|
39.9%
91/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
47.3%
106/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Constipation
|
30.7%
70/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
25.9%
58/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Abdominal pain
|
18.4%
42/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
14.3%
32/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Vomiting
|
18.9%
43/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
22.3%
50/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
38/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
15.6%
35/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Stomatitis
|
13.6%
31/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
4.9%
11/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
19/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
5.8%
13/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Dyspepsia
|
7.9%
18/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
3.1%
7/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Abdominal distension
|
7.0%
16/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
5.4%
12/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Gastrointestinal disorders
Dry mouth
|
5.3%
12/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
1.8%
4/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
General disorders
Fatigue
|
43.0%
98/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
38.4%
86/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
General disorders
Pyrexia
|
25.4%
58/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
12.5%
28/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
General disorders
Asthenia
|
20.2%
46/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
22.8%
51/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
General disorders
Oedema peripheral
|
11.8%
27/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
7.6%
17/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Infections and infestations
Urinary tract infection
|
10.1%
23/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
4.9%
11/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Infections and infestations
Upper respiratory tract infection
|
8.8%
20/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
4.0%
9/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Investigations
Aspartate aminotransferase increased
|
9.2%
21/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
2.2%
5/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Investigations
Neutrophil count decreased
|
8.3%
19/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
5.4%
12/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Investigations
Alanine aminotransferase increased
|
7.9%
18/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
3.6%
8/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Investigations
White blood cell count decreased
|
7.0%
16/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
6.7%
15/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Investigations
Electrocardiogram QT prolonged
|
6.1%
14/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
4.9%
11/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.3%
12/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
3.1%
7/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Investigations
Platelet count decreased
|
0.88%
2/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
7.6%
17/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.9%
43/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
19.2%
43/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.1%
23/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
4.0%
9/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.5%
17/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
2.7%
6/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.5%
33/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
13.8%
31/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.1%
23/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
7.6%
17/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.8%
20/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
8.0%
18/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
19/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
5.8%
13/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.7%
13/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
3.1%
7/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.3%
12/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
4.9%
11/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.2%
46/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
3.6%
8/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Nervous system disorders
Headache
|
18.0%
41/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
9.4%
21/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Nervous system disorders
Dizziness
|
9.2%
21/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
7.1%
16/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Nervous system disorders
Paraesthesia
|
8.8%
20/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
3.1%
7/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Nervous system disorders
Dysgeusia
|
7.9%
18/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
2.2%
5/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Psychiatric disorders
Insomnia
|
9.6%
22/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
4.5%
10/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Psychiatric disorders
Anxiety
|
5.3%
12/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
6.2%
14/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.1%
39/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
12.5%
28/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.9%
34/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
14.7%
33/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.3%
12/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
2.2%
5/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
34.6%
79/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
2.7%
6/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
|
Vascular disorders
Hypotension
|
5.7%
13/228 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
1.8%
4/224 • From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place