Trial Outcomes & Findings for Efficacy and Safety Study of PCI-32765 Combine With Ofatumumab in CLL (NCT NCT01217749)
NCT ID: NCT01217749
Last Updated: 2015-06-25
Results Overview
The primary endpoint for the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR), CR with incomplete blood count recovery (Cri), or partial response (PR), according to the guidelines from the International Workshop on Chronic Lymphocytic Leukemia (IWCLL1) published in 2008 for CLL participants and International Working Group for non-Hodgkin's lymphoma (IWG NHL) 2007 criteria for SLL participants, with the modification that treatment-related lymphocytosis will not be considered progressive disease, as evaluated by the investigators. Assessment of disease is based on radiological exams, physical exam, hematological evaluations and, when appropriate, bone marrow results.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
71 participants
Primary outcome timeframe
The median follow-up time on study for all treated participants is 12.5 (range 0.5-19.6) months
Results posted on
2015-06-25
Participant Flow
Participant milestones
| Measure |
Group 1
In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
|
Group 2
In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
|
Group 3
In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
20
|
24
|
|
Overall Study
COMPLETED
|
24
|
17
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Study of PCI-32765 Combine With Ofatumumab in CLL
Baseline characteristics by cohort
| Measure |
Group 1
n=27 Participants
In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
|
Group 2
n=20 Participants
In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
|
Group 3
n=24 Participants
In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
40 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
31 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
49 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=93 Participants
|
20 participants
n=4 Participants
|
24 participants
n=27 Participants
|
71 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: The median follow-up time on study for all treated participants is 12.5 (range 0.5-19.6) monthsThe primary endpoint for the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR), CR with incomplete blood count recovery (Cri), or partial response (PR), according to the guidelines from the International Workshop on Chronic Lymphocytic Leukemia (IWCLL1) published in 2008 for CLL participants and International Working Group for non-Hodgkin's lymphoma (IWG NHL) 2007 criteria for SLL participants, with the modification that treatment-related lymphocytosis will not be considered progressive disease, as evaluated by the investigators. Assessment of disease is based on radiological exams, physical exam, hematological evaluations and, when appropriate, bone marrow results.
Outcome measures
| Measure |
Group 1
n=27 Participants
In Group 1, PCI-32765 420 mg PO administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
|
Group 2
n=20 Participants
In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
|
Group 3
n=24 Participants
In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
|
|---|---|---|---|
|
Percentage of Participants Achieving Response
|
92.6 percentage of participants
Interval 75.7 to 99.1
|
80.0 percentage of participants
Interval 56.3 to 94.3
|
70.8 percentage of participants
Interval 48.9 to 87.4
|
PRIMARY outcome
Timeframe: 56 days for Group 1 and 28 days for Group 2Number of dose-limiting toxicities observed in the first 6 participants enrolled in treatment Groups 1 and 2
Outcome measures
| Measure |
Group 1
n=6 Participants
In Group 1, PCI-32765 420 mg PO administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
|
Group 2
n=6 Participants
In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
|
Group 3
In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
|
|---|---|---|---|
|
Safety During Dose-Limiting Toxicity (DLT) Observation Period
|
0 participants who experienced DLT
|
0 participants who experienced DLT
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment to within 30 days of last dose or until study closureNumber of participants who had experienced at least one treatment emergent AE
Outcome measures
| Measure |
Group 1
n=27 Participants
In Group 1, PCI-32765 420 mg PO administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
|
Group 2
n=20 Participants
In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
|
Group 3
n=24 Participants
In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs)
|
27 participants
|
20 participants
|
24 participants
|
SECONDARY outcome
Timeframe: From first dose of study treatment until disease progression, death, or until 12 monthsProgressive disease for CLL (Hallek) is characterized by ≥1 of the following: * Appearance of any new lesion, eg lymph nodes (\> 1.5 cm), de novo hepatomegaly or splenomegaly, or other organ infiltrates * Increase of ≥50% * in longest diameter of any previous site * in hepatomegaly or splenomegaly * in blood lymphocytes with ≥5x109/L B cells with enlarging lymph node, liver, or spleen Progressive disease for B cell lymphoma (Cheson) is characterized by any new lesion or increase by ≥ 50% of previously involved sites from nadir: * Appearance of a new lesion(s) \>1.5 cm in any axis, ≥ 50% increase in the SPD of \>1 node, or ≥50% increase in longest diameter of a previously identified node \>1 cm in short axis * Lesions PET+ if FDG-avid lymphoma or PET+ before therapy * 50% increase from nadir in the SPD of any liver or spleen lesions * New or recurrent BM involvement * Increase of ≥50% in blood lymphocytes with ≥5x109/L B cells within enlarging lymph node, liver, or spleen
Outcome measures
| Measure |
Group 1
n=27 Participants
In Group 1, PCI-32765 420 mg PO administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
|
Group 2
n=20 Participants
In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
|
Group 3
n=24 Participants
In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
|
|---|---|---|---|
|
Progression Free Survival (PFS) at 12 Months
|
88.7 percentage of event free participants
Interval 69.0 to 96.2
|
85.0 percentage of event free participants
Interval 60.4 to 94.9
|
75.0 percentage of event free participants
Interval 52.6 to 87.9
|
Adverse Events
Group 1
Serious events: 12 serious events
Other events: 27 other events
Deaths: 0 deaths
Group 2
Serious events: 9 serious events
Other events: 20 other events
Deaths: 0 deaths
Group 3
Serious events: 10 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=27 participants at risk
In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
|
Group 2
n=20 participants at risk
In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
|
Group 3
n=24 participants at risk
In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Cardiac disorders
Atrial fibrillation
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Cardiac disorders
Cardio-respiratory arrest
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Cardiac disorders
Myocardial infarction
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Gastric ulcer
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
General disorders
Pyrexia
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Pneumonia
|
14.8%
4/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
15.0%
3/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
16.7%
4/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Cellulitis
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
8.3%
2/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Sepsis
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Atypical pneumonia
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Gastroenteritis
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Pneumonia pseudomonas aeruginosa
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Metabolism and nutrition disorders
Dehydration
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Metabolism and nutrition disorders
Fluid overload
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Metabolism and nutrition disorders
Gout
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Richter's syndrome
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Nervous system disorders
VIIth nerve paralysis
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Renal and urinary disorders
Urinary retention
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
8.3%
2/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
Other adverse events
| Measure |
Group 1
n=27 participants at risk
In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
|
Group 2
n=20 participants at risk
In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
|
Group 3
n=24 participants at risk
In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Glossodynia
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Paraesthesia oral
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Toothache
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Abdominal hernia
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Ascites
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Constipation
|
14.8%
4/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Dysphagia
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Eructation
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Flatulence
|
11.1%
3/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Gingival pain
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Haematemesis
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Inguinal hernia
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Tongue blistering
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Vomiting
|
14.8%
4/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
15.0%
3/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
General disorders
Oedema peripheral
|
25.9%
7/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
10.0%
2/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
16.7%
4/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
General disorders
Chills
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
12.5%
3/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
General disorders
Pain
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
8.3%
2/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
General disorders
Chest discomfort
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
General disorders
Chest pain
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
General disorders
Fatigue
|
48.1%
13/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
General disorders
Localised oedema
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
General disorders
Asthenia
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
General disorders
Axillary pain
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
General disorders
Catheter site pain
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
General disorders
Catheter site rash
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
General disorders
Injection site bruising
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
General disorders
Irritability
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
General disorders
Pyrexia
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
General disorders
Temperature intolerance
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Hepatobiliary disorders
Liver disorder
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Hepatobiliary disorders
Portal hypertension
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Immune system disorders
Sarcoidosis
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Upper respiratory tract infection
|
25.9%
7/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
40.0%
8/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
20.8%
5/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.8%
4/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
25.0%
5/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
12.5%
3/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Blood and lymphatic system disorders
Anaemia
|
25.9%
7/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
10.0%
2/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
8.3%
2/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
37.0%
10/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
25.0%
5/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
8.3%
2/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
8.3%
2/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Cardiac disorders
Left ventricular dysfunction
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Cardiac disorders
Palpitations
|
11.1%
3/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Ear and labyrinth disorders
Ear pain
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
8.3%
2/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Ear and labyrinth disorders
Haematotympanum
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Ear and labyrinth disorders
Motion sickness
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Ear and labyrinth disorders
Tinnitus
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
12.5%
3/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Eye disorders
Eye pain
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Eye disorders
Vision blurred
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
15.0%
3/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Eye disorders
Cataract
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Eye disorders
Conjunctivitis
|
14.8%
4/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Eye disorders
Intraocular haematoma
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Eye disorders
Iridocyclitis
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Eye disorders
Iris adhesions
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Eye disorders
Ocular hyperaemia
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Eye disorders
Photophobia
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
18/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
80.0%
16/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
66.7%
16/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Stomatitis
|
40.7%
11/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
45.0%
9/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
29.2%
7/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Nausea
|
18.5%
5/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
30.0%
6/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
25.0%
6/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Abdominal distension
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
8.3%
2/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
3/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
8.3%
2/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
3/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
10.0%
2/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
8.3%
2/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Dyspepsia
|
18.5%
5/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
20.0%
4/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
8.3%
2/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
8.3%
2/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Sinusitis
|
22.2%
6/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
10.0%
2/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
12.5%
3/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Urinary tract infection
|
18.5%
5/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
10.0%
2/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
12.5%
3/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Bronchitis
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Cellulitis
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Ear infection
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Infection
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Nasal abscess
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Oral herpes
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
10.0%
2/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Eye infection
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
10.0%
2/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Eye infection toxoplasmal
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Folliculitis
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Fungal skin infection
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Furuncle
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Gastroenteritis viral
|
14.8%
4/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Herpes simplex
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Herpes zoster
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Infected bites
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Lower respiratory tract infection
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Onychomycosis
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Otitis media
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Pneumonia
|
22.2%
6/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
15.0%
3/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Rash pustular
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Skin infection
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Staphylococcal bacteraemia
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Tinea infection
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Tinea pedis
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
33.3%
9/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
70.0%
14/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
37.5%
9/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Injury, poisoning and procedural complications
Contusion
|
33.3%
9/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
40.0%
8/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
12.5%
3/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
25.0%
5/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Injury, poisoning and procedural complications
Animal bite
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Injury, poisoning and procedural complications
Laceration
|
11.1%
3/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Injury, poisoning and procedural complications
Periorbital contusion
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Injury, poisoning and procedural complications
Skin wound
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Injury, poisoning and procedural complications
Wound
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Investigations
Neutrophil count decreased
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
10.0%
2/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Investigations
Blood creatinine increased
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Investigations
Grip strength decreased
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Investigations
International normalised ratio increased
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Investigations
Weight decreased
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Investigations
Weight increased
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
8.3%
2/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
18.5%
5/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
10.0%
2/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
8.3%
2/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.8%
4/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
10.0%
2/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Metabolism and nutrition disorders
Dehydration
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Metabolism and nutrition disorders
Gout
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
14.8%
4/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
10.0%
2/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.1%
3/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.5%
5/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
10.0%
2/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
20.8%
5/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
22.2%
6/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
15.0%
3/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
12.5%
3/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
37.0%
10/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
20.0%
4/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
8.3%
2/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
10.0%
2/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
8.3%
2/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
8.3%
2/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
3/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
40.7%
11/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
40.0%
8/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
50.0%
12/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Nervous system disorders
Headache
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
12.5%
3/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Nervous system disorders
Dizziness
|
14.8%
4/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
20.0%
4/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Nervous system disorders
Dizziness postural
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Nervous system disorders
Dysgeusia
|
14.8%
4/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Nervous system disorders
Hypoaesthesia
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Nervous system disorders
Neuropathy peripheral
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Psychiatric disorders
Anxiety
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Psychiatric disorders
Confusional state
|
14.8%
4/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Psychiatric disorders
Insomnia
|
18.5%
5/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
30.0%
6/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Renal and urinary disorders
Chromaturia
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Renal and urinary disorders
Renal failure acute
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Renal and urinary disorders
Urinary retention
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
10.0%
2/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
16.7%
4/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
3/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
12.5%
3/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
3/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
15.0%
3/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
8.3%
2/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
3/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
11.1%
3/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord cyst
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
11.1%
3/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
15.0%
3/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
22.2%
6/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
25.0%
5/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
25.0%
6/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
3/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
10.0%
2/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
20.8%
5/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
10.0%
2/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
12.5%
3/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
8.3%
2/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
8.3%
2/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
8.3%
2/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
10.0%
2/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Leukocytoclastic vasculitis
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
10.0%
2/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
15.0%
3/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
11.1%
3/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
10.0%
2/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
11.1%
3/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Vascular disorders
Hypertension
|
18.5%
5/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
8.3%
2/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Vascular disorders
Flushing
|
14.8%
4/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
10.0%
2/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
4.2%
1/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Vascular disorders
Haematoma
|
0.00%
0/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
5.0%
1/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Vascular disorders
Hypotension
|
7.4%
2/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
15.0%
3/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
|
Vascular disorders
Peripheral artery aneurysm
|
3.7%
1/27 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/20 • From first dose of study treatment to within 30 days of last dose or until study closure
|
0.00%
0/24 • From first dose of study treatment to within 30 days of last dose or until study closure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place