Trial Outcomes & Findings for A Trial of Panobinostat and Trastuzumab for Adult Female Patients With HER2 Positive Metastatic Breast Cancer (MBC) Whose Disease Has Progressed on or After Trastuzumab (NCT NCT00567879)
NCT ID: NCT00567879
Last Updated: 2016-05-09
Results Overview
Safety data was reviewed to determine the DLTs. DLTs comprised adverse events (AEs) or abnormal laboratory values that occurred at any time and were assessed as clinically relevant and meeting any of the following criteria: considered to be related to the study treatment and unrelated to disease, disease progression, inter-current illness, or concomitant medications. Toxicities were assessed using the National Cancer Institute common terminology criteria for adverse events (NCI CTCAE), version 3.0. Disease related symptoms were not considered a DLT.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
56 participants
Primary outcome timeframe
day 21
Results posted on
2016-05-09
Participant Flow
Eligible participants were allocated to dose escalation arm 1 (i.v. panobinostat) or arm 2 (oral panobinostat) according to a pre-determined sequence in the ratio 1:1. Each cohort consisted of newly enrolled participants. This study included a dose escalation phase to establish the maximum tolerated dose (MTD) and a dose expansion phase.
Participant milestones
| Measure |
Escalation: i.v. Arm - 10mg/m^2
10 mg/m\^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
|
Escalation: i.v. Arm - 15mg/m^2
15 mg/m\^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
|
Escalation/Expansion: i.v. Arm -20mg/m^2
20 mg/m\^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
|
Oral Arm - Schedule A 20mg
20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
|
Oral Arm - Schedule B 15 mg
15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
|
Oral Arm - Schedule B 20mg
20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
21
|
6
|
12
|
3
|
|
Overall Study
Maximum Tolerated Dose Determining Set
|
5
|
7
|
18
|
6
|
12
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
21
|
6
|
12
|
3
|
Reasons for withdrawal
| Measure |
Escalation: i.v. Arm - 10mg/m^2
10 mg/m\^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
|
Escalation: i.v. Arm - 15mg/m^2
15 mg/m\^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
|
Escalation/Expansion: i.v. Arm -20mg/m^2
20 mg/m\^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
|
Oral Arm - Schedule A 20mg
20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
|
Oral Arm - Schedule B 15 mg
15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
|
Oral Arm - Schedule B 20mg
20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Abnormal test procedure(s)
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
3
|
1
|
0
|
0
|
|
Overall Study
New cancer therapy
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Disease progression
|
5
|
7
|
15
|
5
|
11
|
3
|
Baseline Characteristics
A Trial of Panobinostat and Trastuzumab for Adult Female Patients With HER2 Positive Metastatic Breast Cancer (MBC) Whose Disease Has Progressed on or After Trastuzumab
Baseline characteristics by cohort
| Measure |
Escalation: i.v. Arm - 10mg/m^2
n=7 Participants
10 mg/m\^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
|
Escalation: i.v. Arm - 15mg/m^2
n=7 Participants
15 mg/m\^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
|
Escalation/Expansion: i.v. Arm -20mg/m^2
n=21 Participants
20 mg/m\^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
|
Oral Arm - Schedule A 20mg
n=6 Participants
20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
|
Oral Arm - Schedule B 15mg
n=12 Participants
15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
|
Oral Arm - Schedule B 20mg
n=3 Participants
20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.0 Years
n=5 Participants
|
49.0 Years
n=7 Participants
|
57.0 Years
n=5 Participants
|
54.5 Years
n=4 Participants
|
53.5 Years
n=21 Participants
|
47.0 Years
n=8 Participants
|
53.0 Years
n=8 Participants
|
|
Sex/Gender, Customized
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
56 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: day 21Population: The Maximum Tolerated Dose (MTD) determining set was used for this analysis. The MTD determining set consisted of all participants who either received sufficient study drug and had sufficient safety evaluations or discontinued due to unacceptable toxicity.
Safety data was reviewed to determine the DLTs. DLTs comprised adverse events (AEs) or abnormal laboratory values that occurred at any time and were assessed as clinically relevant and meeting any of the following criteria: considered to be related to the study treatment and unrelated to disease, disease progression, inter-current illness, or concomitant medications. Toxicities were assessed using the National Cancer Institute common terminology criteria for adverse events (NCI CTCAE), version 3.0. Disease related symptoms were not considered a DLT.
Outcome measures
| Measure |
Escalation: i.v. Arm - 10mg/m^2
n=5 Participants
10 mg/m\^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
|
Escalation: i.v. Arm - 15mg/m^2
n=7 Participants
15 mg/m\^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
|
Escalation/Expansion: i.v. Arm -20mg/m^2
n=12 Participants
20 mg/m\^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
|
Expansion: i.v. Arm -20mg/m^2
n=6 Participants
20 mg/m\^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
|
Oral Arm - Schedule A 20mg
n=6 Participants
20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
|
Oral Arm - Schedule B 15 mg
n=12 Participants
15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
|
Oral Arm - Schedule B 20mg
n=3 Participants
20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: day 21Population: The full analysis set was analyzed. The full analysis set included all randomized participants.
Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST). Complete response (CR): disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR): \> 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; Progressive disease (PD): \> 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.
Outcome measures
| Measure |
Escalation: i.v. Arm - 10mg/m^2
n=7 Participants
10 mg/m\^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
|
Escalation: i.v. Arm - 15mg/m^2
n=7 Participants
15 mg/m\^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
|
Escalation/Expansion: i.v. Arm -20mg/m^2
n=21 Participants
20 mg/m\^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
|
Expansion: i.v. Arm -20mg/m^2
n=6 Participants
20 mg/m\^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
|
Oral Arm - Schedule A 20mg
n=12 Participants
20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
|
Oral Arm - Schedule B 15 mg
n=3 Participants
15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
|
Oral Arm - Schedule B 20mg
20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Best Overall Response
Complete response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Best Overall Response
Partial response
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Best Overall Response
Stable disease
|
4 Participants
|
1 Participants
|
8 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
|
Number of Participants With Best Overall Response
Progressive disease
|
3 Participants
|
6 Participants
|
9 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
—
|
|
Number of Participants With Best Overall Response
Unknown
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
Adverse Events
Escalation: i.v. Arm - 10mg/m^2
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Escalation: i.v. Arm - 15mg/m^2
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Escalation/Expansion: i.v. Arm -20mg/m^2
Serious events: 5 serious events
Other events: 21 other events
Deaths: 0 deaths
Oral Arm - Schedule A 20mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Oral Arm - Schedule B 15 mg
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Oral Arm - Schedule B 20mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Escalation: i.v. Arm - 10mg/m^2
n=7 participants at risk
10 mg/m\^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
|
Escalation: i.v. Arm - 15mg/m^2
n=7 participants at risk
15 mg/m\^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
|
Escalation/Expansion: i.v. Arm -20mg/m^2
n=21 participants at risk
20 mg/m\^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
|
Oral Arm - Schedule A 20mg
n=6 participants at risk
20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
|
Oral Arm - Schedule B 15 mg
n=12 participants at risk
15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
|
Oral Arm - Schedule B 20mg
n=3 participants at risk
20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/7
|
0.00%
0/7
|
4.8%
1/21
|
16.7%
1/6
|
0.00%
0/12
|
33.3%
1/3
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Eye disorders
Visual impairment
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Gastrointestinal disorders
Oedematous pancreatitis
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Gastrointestinal disorders
Pancreatic duct obstruction
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Gastrointestinal disorders
Pancreatitis
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
General disorders
Asthenia
|
0.00%
0/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
General disorders
General physical health deterioration
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Infections and infestations
Sepsis
|
0.00%
0/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Infections and infestations
Stenotrophomonas infection
|
0.00%
0/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Investigations
Blood amylase increased
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
3/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Nervous system disorders
Balance disorder
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Nervous system disorders
Headache
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Nervous system disorders
Syncope
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/7
|
0.00%
0/7
|
9.5%
2/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/3
|
Other adverse events
| Measure |
Escalation: i.v. Arm - 10mg/m^2
n=7 participants at risk
10 mg/m\^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
|
Escalation: i.v. Arm - 15mg/m^2
n=7 participants at risk
15 mg/m\^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
|
Escalation/Expansion: i.v. Arm -20mg/m^2
n=21 participants at risk
20 mg/m\^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
|
Oral Arm - Schedule A 20mg
n=6 participants at risk
20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
|
Oral Arm - Schedule B 15 mg
n=12 participants at risk
15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
|
Oral Arm - Schedule B 20mg
n=3 participants at risk
20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/7
|
14.3%
1/7
|
14.3%
3/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Anisocytosis
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/7
|
28.6%
2/7
|
0.00%
0/21
|
16.7%
1/6
|
16.7%
2/12
|
33.3%
1/3
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
1/7
|
42.9%
3/7
|
14.3%
3/21
|
16.7%
1/6
|
41.7%
5/12
|
33.3%
1/3
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/7
|
14.3%
1/7
|
42.9%
9/21
|
50.0%
3/6
|
41.7%
5/12
|
33.3%
1/3
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
33.3%
1/3
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Cardiac disorders
Cardiac flutter
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Cardiac disorders
Left ventricular dysfunction
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/21
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Cardiac disorders
Palpitations
|
0.00%
0/7
|
14.3%
1/7
|
9.5%
2/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/7
|
14.3%
1/7
|
4.8%
1/21
|
16.7%
1/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Ear and labyrinth disorders
Vertigo
|
28.6%
2/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/7
|
14.3%
1/7
|
4.8%
1/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/7
|
28.6%
2/7
|
0.00%
0/21
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Eye disorders
Dry eye
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/7
|
0.00%
0/7
|
9.5%
2/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7
|
14.3%
1/7
|
14.3%
3/21
|
0.00%
0/6
|
16.7%
2/12
|
0.00%
0/3
|
|
Gastrointestinal disorders
Abdominal pain upper
|
28.6%
2/7
|
14.3%
1/7
|
9.5%
2/21
|
33.3%
2/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7
|
14.3%
1/7
|
19.0%
4/21
|
16.7%
1/6
|
33.3%
4/12
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhoea
|
28.6%
2/7
|
0.00%
0/7
|
38.1%
8/21
|
50.0%
3/6
|
58.3%
7/12
|
66.7%
2/3
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/7
|
0.00%
0/7
|
19.0%
4/21
|
0.00%
0/6
|
25.0%
3/12
|
0.00%
0/3
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
3/21
|
16.7%
1/6
|
25.0%
3/12
|
33.3%
1/3
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Gastrointestinal disorders
Haemorrhoids
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Gastrointestinal disorders
Nausea
|
57.1%
4/7
|
71.4%
5/7
|
66.7%
14/21
|
66.7%
4/6
|
33.3%
4/12
|
66.7%
2/3
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/7
|
0.00%
0/7
|
4.8%
1/21
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Gastrointestinal disorders
Stomatitis
|
28.6%
2/7
|
28.6%
2/7
|
23.8%
5/21
|
16.7%
1/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Gastrointestinal disorders
Toothache
|
14.3%
1/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7
|
28.6%
2/7
|
33.3%
7/21
|
50.0%
3/6
|
16.7%
2/12
|
33.3%
1/3
|
|
General disorders
Asthenia
|
71.4%
5/7
|
57.1%
4/7
|
19.0%
4/21
|
50.0%
3/6
|
8.3%
1/12
|
66.7%
2/3
|
|
General disorders
Catheter site erythema
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
General disorders
Chest pain
|
14.3%
1/7
|
14.3%
1/7
|
9.5%
2/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
General disorders
Chills
|
0.00%
0/7
|
28.6%
2/7
|
14.3%
3/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
General disorders
Fatigue
|
14.3%
1/7
|
42.9%
3/7
|
33.3%
7/21
|
33.3%
2/6
|
41.7%
5/12
|
0.00%
0/3
|
|
General disorders
Gait disturbance
|
0.00%
0/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
0.00%
0/12
|
33.3%
1/3
|
|
General disorders
Influenza like illness
|
0.00%
0/7
|
0.00%
0/7
|
23.8%
5/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
General disorders
Irritability
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
General disorders
Mucosal inflammation
|
0.00%
0/7
|
0.00%
0/7
|
9.5%
2/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
General disorders
Oedema peripheral
|
0.00%
0/7
|
0.00%
0/7
|
19.0%
4/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
General disorders
Pain
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
General disorders
Pyrexia
|
14.3%
1/7
|
14.3%
1/7
|
14.3%
3/21
|
33.3%
2/6
|
25.0%
3/12
|
0.00%
0/3
|
|
General disorders
Thrombosis in device
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Infections and infestations
Bronchiolitis
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Infections and infestations
Bronchitis
|
0.00%
0/7
|
0.00%
0/7
|
9.5%
2/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Infections and infestations
Ear infection
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/7
|
0.00%
0/7
|
4.8%
1/21
|
16.7%
1/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Infections and infestations
Gastroenteritis viral
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Infections and infestations
Hordeolum
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Infections and infestations
Influenza
|
14.3%
1/7
|
14.3%
1/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
3/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Infections and infestations
Pharyngitis
|
14.3%
1/7
|
14.3%
1/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Infections and infestations
Rhinitis
|
14.3%
1/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
3/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/7
|
0.00%
0/7
|
14.3%
3/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Joint sprain
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Investigations
Alanine aminotransferase increased
|
28.6%
2/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Investigations
Aspartate aminotransferase increased
|
28.6%
2/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Investigations
Blood alkaline phosphatase increased
|
14.3%
1/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Investigations
Blood amylase increased
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Investigations
Blood creatinine increased
|
42.9%
3/7
|
14.3%
1/7
|
4.8%
1/21
|
0.00%
0/6
|
0.00%
0/12
|
33.3%
1/3
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
33.3%
1/3
|
|
Investigations
Blood urine present
|
0.00%
0/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Investigations
Cardiac murmur
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Investigations
Ejection fraction decreased
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Investigations
Electrocardiogram QT prolonged
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Investigations
Electrocardiogram QT shortened
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Investigations
Electrocardiogram ST segment abnormal
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/7
|
0.00%
0/7
|
9.5%
2/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Investigations
Lipase increased
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Investigations
Neutrophil count increased
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Investigations
Weight decreased
|
0.00%
0/7
|
0.00%
0/7
|
9.5%
2/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Investigations
White blood cell count increased
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/7
|
0.00%
0/7
|
38.1%
8/21
|
0.00%
0/6
|
33.3%
4/12
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
28.6%
2/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
14.3%
1/7
|
0.00%
0/7
|
9.5%
2/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/7
|
14.3%
1/7
|
14.3%
3/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/7
|
0.00%
0/7
|
9.5%
2/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7
|
14.3%
1/7
|
14.3%
3/21
|
33.3%
2/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7
|
14.3%
1/7
|
19.0%
4/21
|
16.7%
1/6
|
33.3%
4/12
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
28.6%
2/7
|
14.3%
1/7
|
14.3%
3/21
|
0.00%
0/6
|
0.00%
0/12
|
33.3%
1/3
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
42.9%
3/7
|
28.6%
2/7
|
28.6%
6/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/7
|
14.3%
1/7
|
4.8%
1/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
14.3%
1/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
1/7
|
14.3%
1/7
|
0.00%
0/21
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
14.3%
1/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
33.3%
1/3
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7
|
14.3%
1/7
|
23.8%
5/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Nervous system disorders
Dysgeusia
|
14.3%
1/7
|
14.3%
1/7
|
47.6%
10/21
|
0.00%
0/6
|
16.7%
2/12
|
0.00%
0/3
|
|
Nervous system disorders
Headache
|
57.1%
4/7
|
85.7%
6/7
|
33.3%
7/21
|
0.00%
0/6
|
41.7%
5/12
|
33.3%
1/3
|
|
Nervous system disorders
Lethargy
|
0.00%
0/7
|
0.00%
0/7
|
9.5%
2/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Nervous system disorders
Neuralgia
|
14.3%
1/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Nervous system disorders
Paraesthesia
|
14.3%
1/7
|
14.3%
1/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
33.3%
1/3
|
|
Nervous system disorders
Somnolence
|
0.00%
0/7
|
0.00%
0/7
|
9.5%
2/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Psychiatric disorders
Agitation
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7
|
28.6%
2/7
|
4.8%
1/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/7
|
0.00%
0/7
|
9.5%
2/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7
|
0.00%
0/7
|
9.5%
2/21
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
33.3%
1/3
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Reproductive system and breast disorders
Breast discharge
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Reproductive system and breast disorders
Breast haemorrhage
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
2/7
|
14.3%
1/7
|
33.3%
7/21
|
0.00%
0/6
|
25.0%
3/12
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
1/7
|
42.9%
3/7
|
33.3%
7/21
|
0.00%
0/6
|
16.7%
2/12
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/7
|
14.3%
1/7
|
4.8%
1/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7
|
14.3%
1/7
|
4.8%
1/21
|
0.00%
0/6
|
25.0%
3/12
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/7
|
0.00%
0/7
|
9.5%
2/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/7
|
14.3%
1/7
|
4.8%
1/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
28.6%
2/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
1/7
|
0.00%
0/7
|
9.5%
2/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
28.6%
2/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
16.7%
2/12
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/7
|
0.00%
0/7
|
9.5%
2/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Lividity
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
14.3%
1/7
|
0.00%
0/7
|
9.5%
2/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Nail toxicity
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7
|
28.6%
2/7
|
9.5%
2/21
|
0.00%
0/6
|
25.0%
3/12
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7
|
0.00%
0/7
|
9.5%
2/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
14.3%
1/7
|
0.00%
0/7
|
9.5%
2/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Vascular disorders
Haematoma
|
0.00%
0/7
|
0.00%
0/7
|
4.8%
1/21
|
0.00%
0/6
|
8.3%
1/12
|
0.00%
0/3
|
|
Vascular disorders
Hot flush
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/21
|
16.7%
1/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Vascular disorders
Hyperaemia
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
|
Vascular disorders
Hypotension
|
0.00%
0/7
|
14.3%
1/7
|
4.8%
1/21
|
0.00%
0/6
|
8.3%
1/12
|
33.3%
1/3
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/7
|
0.00%
0/7
|
9.5%
2/21
|
0.00%
0/6
|
16.7%
2/12
|
0.00%
0/3
|
|
Vascular disorders
Phlebitis
|
0.00%
0/7
|
14.3%
1/7
|
0.00%
0/21
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/3
|
Additional Information
Study Director
Novartis
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER