Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Eribulin Mesylate Administered Biweekly (Q2W) for Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic Breast Cancer (NCT NCT02481050)
NCT ID: NCT02481050
Last Updated: 2018-11-15
Results Overview
ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) measured by response evaluation criteria in solid tumors (RECIST) 1.1. CR defined as disappearance of all target lesions (a short diameter is less than \[\<\] 10 millimeter \[mm\] if it exists in a lymph node). PR defined as at least 30 percent (%) decrease in the sum of the long diameter (LD) of all target lesions, as compared with Baseline summed LD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
From first dose of study drug until intercurrent illness, unacceptable toxicity, disease progression, or until the participant withdrew consent (approximately up to 2.3 years)
Results posted on
2018-11-15
Participant Flow
Participants took part in the study at 12 investigative sites in the United States from 16 June 2015 to 05 September 2017.
A total of 74 participants were screened, of which 16 were screen failures and 58 were randomized to receive study treatment.
Participant milestones
| Measure |
Eribulin Mesylate 1.4 mg/m^2
Participants with histologically confirmed human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC) who were previously treated with 2 to 5 chemotherapy regimens received eribulin mesylate 1.4 milligram per square meter (mg/m\^2), intravenous infusion over 2 to 5 minutes on Day 1 and Day 15 of each 28-days treatment cycle until intercurrent illness, unacceptable toxicity, disease progression occurred, or until the participant withdrew consent (up to 16 cycles).
|
|---|---|
|
Overall Study
STARTED
|
58
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
58
|
Reasons for withdrawal
| Measure |
Eribulin Mesylate 1.4 mg/m^2
Participants with histologically confirmed human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC) who were previously treated with 2 to 5 chemotherapy regimens received eribulin mesylate 1.4 milligram per square meter (mg/m\^2), intravenous infusion over 2 to 5 minutes on Day 1 and Day 15 of each 28-days treatment cycle until intercurrent illness, unacceptable toxicity, disease progression occurred, or until the participant withdrew consent (up to 16 cycles).
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Disease Progression
|
47
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Other
|
3
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of Eribulin Mesylate Administered Biweekly (Q2W) for Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Eribulin Mesylate 1.4 mg/m^2
n=58 Participants
Participants with histologically confirmed HER2-negative MBC who were previously treated with 2 to 5 chemotherapy regimens received eribulin mesylate 1.4 mg/m\^2, intravenous infusion over 2 to 5 minutes on Day 1 and Day 15 of each 28-days treatment cycle until intercurrent illness, unacceptable toxicity, disease progression occurred, or until the participant withdrew consent (up to 16 cycles).
|
|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 9.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug until intercurrent illness, unacceptable toxicity, disease progression, or until the participant withdrew consent (approximately up to 2.3 years)Population: The evaluable analysis set (EAS) included all participants who had both an evaluable baseline tumor assessment and an evaluable postbaseline tumor assessment, unless the participants discontinued because of disease progression or toxicity.
ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) measured by response evaluation criteria in solid tumors (RECIST) 1.1. CR defined as disappearance of all target lesions (a short diameter is less than \[\<\] 10 millimeter \[mm\] if it exists in a lymph node). PR defined as at least 30 percent (%) decrease in the sum of the long diameter (LD) of all target lesions, as compared with Baseline summed LD.
Outcome measures
| Measure |
Eribulin Mesylate 1.4 mg/m^2
n=57 Participants
Participants with histologically confirmed HER2-negative MBC who were previously treated with 2 to 5 chemotherapy regimens received eribulin mesylate 1.4 mg/m\^2, intravenous infusion over 2 to 5 minutes on Day 1 and Day 15 of each 28-days treatment cycle until intercurrent illness, unacceptable toxicity, disease progression occurred, or until the participant withdrew consent (up to 16 cycles).
|
|---|---|
|
Objective Response Rate (ORR) by Investigator Assessment
|
12.3 percentage of participants
Interval 5.08 to 23.68
|
PRIMARY outcome
Timeframe: From first dose of study drug until intercurrent illness, unacceptable toxicity, disease progression, or until the participant withdrew consent (approximately up to 2.3 years)Population: The EAS included all participants who had both an evaluable baseline tumor assessment and an evaluable postbaseline tumor assessment, unless the participants discontinued because of disease progression or toxicity.
DCR was defined as the percentage of participants who had BOR of CR, PR, or stable disease (SD) measured by RECIST 1.1. CR defined as disappearance of all target lesions (a short diameter is \<10 mm if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with Baseline summed LD. SD defined as reduction in tumor volume of less than 50% or an increase in the volume of 1 or more measurable lesions of less than 25% without the appearance of any new lesions which was neither tumor shrinkage corresponding to PR nor tumor expansion corresponding to disease progression. SD must be achieved at greater than equal to (\>=) 7 weeks after the first eribulin administration to be considered BOR.
Outcome measures
| Measure |
Eribulin Mesylate 1.4 mg/m^2
n=57 Participants
Participants with histologically confirmed HER2-negative MBC who were previously treated with 2 to 5 chemotherapy regimens received eribulin mesylate 1.4 mg/m\^2, intravenous infusion over 2 to 5 minutes on Day 1 and Day 15 of each 28-days treatment cycle until intercurrent illness, unacceptable toxicity, disease progression occurred, or until the participant withdrew consent (up to 16 cycles).
|
|---|---|
|
Disease Control Rate (DCR) by Investigator Assessment
|
64.9 percentage of participants
Interval 51.13 to 77.09
|
SECONDARY outcome
Timeframe: From first dose of study drug until intercurrent illness, unacceptable toxicity, disease progression, or until the participant withdrew consent (approximately up to 2.3 years)Population: The FAS included all participants who received any amount of study drug.
PFS was defined as the time from date of first dose of study drug to the date of disease progression or death, whichever occurred first.
Outcome measures
| Measure |
Eribulin Mesylate 1.4 mg/m^2
n=58 Participants
Participants with histologically confirmed HER2-negative MBC who were previously treated with 2 to 5 chemotherapy regimens received eribulin mesylate 1.4 mg/m\^2, intravenous infusion over 2 to 5 minutes on Day 1 and Day 15 of each 28-days treatment cycle until intercurrent illness, unacceptable toxicity, disease progression occurred, or until the participant withdrew consent (up to 16 cycles).
|
|---|---|
|
Progression-Free Survival (PFS) by Investigator Assessment
|
3.6 months
Interval 2.86 to 4.07
|
SECONDARY outcome
Timeframe: From date of first dose of study drug administration until date of death from any cause (approximately up to 2.3 years)Population: The FAS included all participants who received any amount of study drug.
OS was defined as the time from date of first dose of study drug until date of death from any cause.
Outcome measures
| Measure |
Eribulin Mesylate 1.4 mg/m^2
n=58 Participants
Participants with histologically confirmed HER2-negative MBC who were previously treated with 2 to 5 chemotherapy regimens received eribulin mesylate 1.4 mg/m\^2, intravenous infusion over 2 to 5 minutes on Day 1 and Day 15 of each 28-days treatment cycle until intercurrent illness, unacceptable toxicity, disease progression occurred, or until the participant withdrew consent (up to 16 cycles).
|
|---|---|
|
Overall Survival (OS)
|
12.9 months
Interval 9.76 to 16.56
|
SECONDARY outcome
Timeframe: Cycle 2 Day 28 and Cycle 4 Day 28 ( cycle length=28 days)Population: The FAS included all participants who received any amount of study drug. The FAS where data at specified timepoints was available.
Feasibility rate is defined as the percentage of participants completing the first 2 and 4 cycles (1 cycle = 28 days) of eribulin mesylate treatment (4 and 8 doses) without requiring dose delay greater than (\>) 5 days or reduction due to adverse event (AE).
Outcome measures
| Measure |
Eribulin Mesylate 1.4 mg/m^2
n=58 Participants
Participants with histologically confirmed HER2-negative MBC who were previously treated with 2 to 5 chemotherapy regimens received eribulin mesylate 1.4 mg/m\^2, intravenous infusion over 2 to 5 minutes on Day 1 and Day 15 of each 28-days treatment cycle until intercurrent illness, unacceptable toxicity, disease progression occurred, or until the participant withdrew consent (up to 16 cycles).
|
|---|---|
|
Feasibility Rate
First 2 cycles
|
69.8 percentage of participants
Interval 55.7 to 81.7
|
|
Feasibility Rate
First 4 cycles
|
50.0 percentage of participants
Interval 28.2 to 71.8
|
SECONDARY outcome
Timeframe: From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)Population: The FAS included all participants who received any amount of study drug.
Outcome measures
| Measure |
Eribulin Mesylate 1.4 mg/m^2
n=58 Participants
Participants with histologically confirmed HER2-negative MBC who were previously treated with 2 to 5 chemotherapy regimens received eribulin mesylate 1.4 mg/m\^2, intravenous infusion over 2 to 5 minutes on Day 1 and Day 15 of each 28-days treatment cycle until intercurrent illness, unacceptable toxicity, disease progression occurred, or until the participant withdrew consent (up to 16 cycles).
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAE
|
58 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAE
|
14 Participants
|
Adverse Events
Eribulin Mesylate 1.4 mg/m^2
Serious events: 14 serious events
Other events: 58 other events
Deaths: 40 deaths
Serious adverse events
| Measure |
Eribulin Mesylate 1.4 mg/m^2
n=58 participants at risk
Participants with histologically confirmed HER2-negative MBC who were previously treated with 2 to 5 chemotherapy regimens received eribulin mesylate 1.4 mg/m\^2, intravenous infusion over 2 to 5 minutes on Day 1 and Day 15 of each 28-days treatment cycle until intercurrent illness, unacceptable toxicity, disease progression occurred, or until the participant withdrew consent (up to 16 cycles).
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
General disorders
Asthenia
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
General disorders
Chest pain
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
General disorders
Pain
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Infections and infestations
Sepsis
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Investigations
Neutrophil count decreased
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Nervous system disorders
Paraesthesia
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
Other adverse events
| Measure |
Eribulin Mesylate 1.4 mg/m^2
n=58 participants at risk
Participants with histologically confirmed HER2-negative MBC who were previously treated with 2 to 5 chemotherapy regimens received eribulin mesylate 1.4 mg/m\^2, intravenous infusion over 2 to 5 minutes on Day 1 and Day 15 of each 28-days treatment cycle until intercurrent illness, unacceptable toxicity, disease progression occurred, or until the participant withdrew consent (up to 16 cycles).
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.3%
6/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.2%
3/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Blood and lymphatic system disorders
Neutropenia
|
43.1%
25/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.2%
3/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Cardiac disorders
Acute myocardial infarction
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Cardiac disorders
Cardiac failure congestive
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Cardiac disorders
Coronary artery disease
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Cardiac disorders
Palpitations
|
5.2%
3/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Cardiac disorders
Tachycardia
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Ear and labyrinth disorders
Deafness unilateral
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Ear and labyrinth disorders
Ear discomfort
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Ear and labyrinth disorders
Ear pain
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Ear and labyrinth disorders
Tinnitus
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Ear and labyrinth disorders
Vestibular disorder
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Eye disorders
Cataract
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Eye disorders
Conjunctival haemorrhage
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Eye disorders
Eye irritation
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Eye disorders
Eye swelling
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Eye disorders
Eyelids pruritus
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Eye disorders
Lacrimation increased
|
12.1%
7/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Eye disorders
Ocular hyperaemia
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Eye disorders
Vision blurred
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Gastrointestinal disorders
Abdominal distension
|
5.2%
3/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
10.3%
6/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.9%
4/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Gastrointestinal disorders
Constipation
|
37.9%
22/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Gastrointestinal disorders
Diarrhoea
|
24.1%
14/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Gastrointestinal disorders
Dry mouth
|
5.2%
3/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Gastrointestinal disorders
Dyspepsia
|
10.3%
6/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Gastrointestinal disorders
Gastritis
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Gastrointestinal disorders
Gingival pain
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Gastrointestinal disorders
Loose tooth
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Gastrointestinal disorders
Nausea
|
29.3%
17/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Gastrointestinal disorders
Stomatitis
|
24.1%
14/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Gastrointestinal disorders
Toothache
|
5.2%
3/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Gastrointestinal disorders
Vomiting
|
12.1%
7/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
General disorders
Asthenia
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
General disorders
Chills
|
5.2%
3/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
General disorders
Early satiety
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
General disorders
Face oedema
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
General disorders
Fatigue
|
55.2%
32/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
General disorders
Gait disturbance
|
5.2%
3/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
General disorders
Localised oedema
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
General disorders
Non-cardiac chest pain
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
General disorders
Oedema peripheral
|
13.8%
8/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
General disorders
Pain
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
General disorders
Peripheral swelling
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
General disorders
Pyrexia
|
12.1%
7/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Immune system disorders
Contrast media allergy
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Immune system disorders
Drug hypersensitivity
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Infections and infestations
Bronchitis viral
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Infections and infestations
Conjunctivitis
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Infections and infestations
Cystitis
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Infections and infestations
Diverticulitis
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Infections and infestations
Ear infection
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Infections and infestations
Eye infection
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Infections and infestations
Hepatitis B
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Infections and infestations
Herpes zoster
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Infections and infestations
Hordeolum
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Infections and infestations
Lung infection
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Infections and infestations
Nasopharyngitis
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Infections and infestations
Oral candidiasis
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Infections and infestations
Oral herpes
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Infections and infestations
Peritonitis
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Infections and infestations
Pneumonia
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Infections and infestations
Sinusitis
|
5.2%
3/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Infections and infestations
Skin bacterial infection
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Infections and infestations
Tooth abscess
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Infections and infestations
Upper respiratory tract infection
|
6.9%
4/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Infections and infestations
Urinary tract infection
|
10.3%
6/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Injury, poisoning and procedural complications
Contusion
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Injury, poisoning and procedural complications
Fall
|
13.8%
8/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Injury, poisoning and procedural complications
Joint injury
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Injury, poisoning and procedural complications
Patella fracture
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Investigations
Aspartate aminotransferase increased
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Investigations
Blood alkaline phosphatase increased
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Investigations
Blood bilirubin increased
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Investigations
Blood pressure diastolic decreased
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Investigations
Lymphocyte count decreased
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Investigations
Neutrophil count decreased
|
37.9%
22/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Investigations
Platelet count decreased
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Investigations
Troponin increased
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Investigations
Weight decreased
|
8.6%
5/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Investigations
Weight increased
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Investigations
White blood cell count decreased
|
6.9%
4/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.0%
11/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
6.9%
4/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.9%
4/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
13.8%
8/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.8%
8/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.1%
7/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.3%
6/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.2%
3/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.6%
5/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
10.3%
6/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
17.2%
10/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.3%
6/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.2%
3/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.9%
4/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Nervous system disorders
Amnesia
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Nervous system disorders
Balance disorder
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Nervous system disorders
Disturbance in attention
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Nervous system disorders
Dizziness
|
6.9%
4/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Nervous system disorders
Dysaesthesia
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Nervous system disorders
Dysgeusia
|
10.3%
6/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Nervous system disorders
Headache
|
12.1%
7/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Nervous system disorders
Hypoaesthesia
|
6.9%
4/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Nervous system disorders
Neuralgia
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
32.8%
19/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Nervous system disorders
Peroneal nerve palsy
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Nervous system disorders
Psychomotor hyperactivity
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Nervous system disorders
Syncope
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Product Issues
Device occlusion
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Psychiatric disorders
Anxiety
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Psychiatric disorders
Confusional state
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Psychiatric disorders
Depression
|
5.2%
3/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Psychiatric disorders
Insomnia
|
5.2%
3/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Psychiatric disorders
Panic attack
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Renal and urinary disorders
Acute kidney injury
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Renal and urinary disorders
Bladder prolapse
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Renal and urinary disorders
Dysuria
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Renal and urinary disorders
Pollakiuria
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Renal and urinary disorders
Proteinuria
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Renal and urinary disorders
Urinary incontinence
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Reproductive system and breast disorders
Breast pain
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.5%
9/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.0%
11/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.2%
3/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.2%
3/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
29/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Skin and subcutaneous tissue disorders
Blister
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.2%
3/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.2%
3/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.4%
2/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Skin and subcutaneous tissue disorders
Skin tightness
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Vascular disorders
Flushing
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Vascular disorders
Hot flush
|
6.9%
4/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Vascular disorders
Hypertension
|
5.2%
3/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Vascular disorders
Thrombosis
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
|
Gastrointestinal disorders
Lip pain
|
1.7%
1/58 • From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place