Trial Outcomes & Findings for Study Evaluating HKI-272 in Tumors (NCT NCT00146172)
NCT ID: NCT00146172
Last Updated: 2018-09-17
Results Overview
DLT is defined as any neratinib-related nonhematologic grade 3 or any grade 4 adverse event (AE) according to the National Cancer Institute (NCI) common terminology criteria (CTC) for AEs version 3.0. DLTs were assessed from the first single dose to 14 days of continuous daily administration.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
73 participants
Primary outcome timeframe
From first dose date to day 14
Results posted on
2018-09-17
Participant Flow
Participant milestones
| Measure |
Neratinib 40 mg
Neratinb 40 mg qd
|
Neratinib 80 mg
Neratinib 80 mg qd
|
Neratinib 120 mg
Neratinib 120 mg qd
|
Neratinib 180 mg
Neratinib 180 mg qd
|
Neratinib 240 mg
Neratinib 240 mg qd
|
Neratinib 320 mg
Neratinib 320 mg qd
|
Neratinib 400 mg
Neratinib 400 mg qd
|
Neratinib MTD
Neratinib maximum tolerated dose (320 mg).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
4
|
6
|
3
|
7
|
6
|
40
|
|
Overall Study
Received Drug
|
3
|
4
|
4
|
6
|
3
|
7
|
6
|
39
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
4
|
6
|
3
|
7
|
6
|
40
|
Reasons for withdrawal
| Measure |
Neratinib 40 mg
Neratinb 40 mg qd
|
Neratinib 80 mg
Neratinib 80 mg qd
|
Neratinib 120 mg
Neratinib 120 mg qd
|
Neratinib 180 mg
Neratinib 180 mg qd
|
Neratinib 240 mg
Neratinib 240 mg qd
|
Neratinib 320 mg
Neratinib 320 mg qd
|
Neratinib 400 mg
Neratinib 400 mg qd
|
Neratinib MTD
Neratinib maximum tolerated dose (320 mg).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
1
|
0
|
2
|
3
|
10
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Disease Progression
|
2
|
4
|
2
|
5
|
2
|
2
|
1
|
22
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
4
|
|
Overall Study
Symptomatic Deterioration
|
1
|
0
|
1
|
0
|
1
|
2
|
0
|
2
|
Baseline Characteristics
Study Evaluating HKI-272 in Tumors
Baseline characteristics by cohort
| Measure |
Neratinib 40 mg
n=3 Participants
Neratinb 40 mg qd
|
Neratinib 80 mg
n=4 Participants
Neratinib 80 mg qd
|
Neratinib 120 mg
n=4 Participants
Neratinib 120 mg qd
|
Neratinib 180 mg
n=6 Participants
Neratinib 180 mg qd
|
Neratinib 240 mg
n=3 Participants
Neratinib 240 mg qd
|
Neratinib 320 mg
n=7 Participants
Neratinib 320 mg qd
|
Neratinib 400 mg
n=6 Participants
Neratinib 400 mg qd
|
Neratinib MTD
n=39 Participants
Neratinib maximum tolerated dose (320 mg) from part 2.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
28 Participants
n=24 Participants
|
54 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
|
Age, Continuous
|
51.33 years
STANDARD_DEVIATION 12.50 • n=5 Participants
|
54.00 years
STANDARD_DEVIATION 7.66 • n=7 Participants
|
56.25 years
STANDARD_DEVIATION 20.43 • n=5 Participants
|
60.67 years
STANDARD_DEVIATION 15.31 • n=4 Participants
|
57.00 years
STANDARD_DEVIATION 8.89 • n=21 Participants
|
63.71 years
STANDARD_DEVIATION 15.70 • n=8 Participants
|
51.33 years
STANDARD_DEVIATION 8.91 • n=8 Participants
|
58.18 years
STANDARD_DEVIATION 11.05 • n=24 Participants
|
57.68 years
STANDARD_DEVIATION 12.06 • n=42 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
26 Participants
n=24 Participants
|
52 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
20 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From first dose date to day 14Population: Subjects in the dosing groups 40 mg through 400 mg, excluding the selection of MTD.
DLT is defined as any neratinib-related nonhematologic grade 3 or any grade 4 adverse event (AE) according to the National Cancer Institute (NCI) common terminology criteria (CTC) for AEs version 3.0. DLTs were assessed from the first single dose to 14 days of continuous daily administration.
Outcome measures
| Measure |
Neratinib 40 mg
n=3 Participants
Neratinb 40 mg qd
|
Neratinib 80 mg
n=4 Participants
Neratinib 80 mg qd
|
Neratinib 120 mg
n=4 Participants
Neratinib 120 mg qd
|
Neratinib 180 mg
n=6 Participants
Neratinib 180 mg qd
|
Neratinib 240 mg
n=3 Participants
Neratinib 240 mg qd
|
Neratinib 320 mg
n=7 Participants
Neratinib 320 mg qd.
|
Neratinib 400 mg
n=6 Participants
Neratinib 400 mg qd
|
|---|---|---|---|---|---|---|---|
|
Dose Limiting Toxicity (DLT)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: From first dose date to day 14Population: All patients receiving neratinib in the dose escalation part of the study.
If 2 or more, of 3 to 6 subjects, at a dose level had an neratinib-related dose limiting toxicity (DLT) by day 14 of continuous daily dose administration, dose escalation stopped and the prior dose level was considered the MTD.
Outcome measures
| Measure |
Neratinib 40 mg
n=33 Participants
Neratinb 40 mg qd
|
Neratinib 80 mg
Neratinib 80 mg qd
|
Neratinib 120 mg
Neratinib 120 mg qd
|
Neratinib 180 mg
Neratinib 180 mg qd
|
Neratinib 240 mg
Neratinib 240 mg qd
|
Neratinib 320 mg
Neratinib 320 mg qd.
|
Neratinib 400 mg
Neratinib 400 mg qd
|
|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
320 mg
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose date to progression or last tumor assessment, up to 39 weeks.Population: Subjects who had received at least 14 days of continuous dose administration of test article and who had undergone at least 1 follow-up tumor assessment, evaluable population
Best Overall response by tumor type, evaluable population per Response Evaluation Criteria In Solid Tumors Criteria v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in sum of the longest diameter (LD) of target lesions in reference to baseline sum of LD of target lesions; Progressive Disease (PD), \>=20% increase in sum of LD of target lesions, taking as reference the smallest sum of recorded LD of target lesions since treatment started or appearance of 1 or more new lesions; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LD of target lesions since the treatment start. The best overall response was the best response recorded from start of treatment until PD/recurrence. In general, the subject's best response assignment depended on achievement of both measurement and confirmation criteria.
Outcome measures
| Measure |
Neratinib 40 mg
n=25 Participants
Neratinb 40 mg qd
|
Neratinib 80 mg
n=14 Participants
Neratinib 80 mg qd
|
Neratinib 120 mg
n=60 Participants
Neratinib 120 mg qd
|
Neratinib 180 mg
Neratinib 180 mg qd
|
Neratinib 240 mg
Neratinib 240 mg qd
|
Neratinib 320 mg
Neratinib 320 mg qd.
|
Neratinib 400 mg
Neratinib 400 mg qd
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Best Overall Response
Partial Response
|
8 Participants
|
0 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Best Overall Response
Stable Disease >=24 weeks
|
1 Participants
|
6 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Best Overall Response
Stable Disease >=16 weeks
|
1 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Best Overall Response
Stable Disease >=8 weeks
|
4 Participants
|
2 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Best Overall Response
Progressive Disease
|
11 Participants
|
6 Participants
|
32 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start date of response to first PD, up to 39 weeks.Population: Subjects responses classified as complete response or partial response in evaluable population
Duration of response of responders (PR+) by Kaplan-Meier estimate
Outcome measures
| Measure |
Neratinib 40 mg
n=8 Participants
Neratinb 40 mg qd
|
Neratinib 80 mg
Neratinib 80 mg qd
|
Neratinib 120 mg
n=8 Participants
Neratinib 120 mg qd
|
Neratinib 180 mg
Neratinib 180 mg qd
|
Neratinib 240 mg
Neratinib 240 mg qd
|
Neratinib 320 mg
Neratinib 320 mg qd.
|
Neratinib 400 mg
Neratinib 400 mg qd
|
|---|---|---|---|---|---|---|---|
|
Duration of Response
|
4.8 months
Interval 1.9 to 9.5
|
—
|
4.8 months
Interval 1.9 to 9.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose date to progression or death, up to 39 weeks.Population: All subjects who were assigned to treatment, received at least 14 days of continuous dose administration of test article, and who had undergone at least 1 follow-up tumor assessment, evaluable population
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Neratinib 40 mg
n=25 Participants
Neratinb 40 mg qd
|
Neratinib 80 mg
n=14 Participants
Neratinib 80 mg qd
|
Neratinib 120 mg
n=60 Participants
Neratinib 120 mg qd
|
Neratinib 180 mg
Neratinib 180 mg qd
|
Neratinib 240 mg
Neratinib 240 mg qd
|
Neratinib 320 mg
Neratinib 320 mg qd.
|
Neratinib 400 mg
Neratinib 400 mg qd
|
|---|---|---|---|---|---|---|---|
|
Progression Free Survival
|
3.6 months
Interval 1.7 to 5.6
|
3.5 months
Interval 1.2 to 9.0
|
1.9 months
Interval 1.7 to 3.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose date to progression/death or last assessment, up to 39 weeksPopulation: Breast, Lung and other solid tumors included in the efficacy evaluable population
Patients with PR or higher responses, evaluable population
Outcome measures
| Measure |
Neratinib 40 mg
n=25 Participants
Neratinb 40 mg qd
|
Neratinib 80 mg
n=14 Participants
Neratinib 80 mg qd
|
Neratinib 120 mg
n=60 Participants
Neratinib 120 mg qd
|
Neratinib 180 mg
Neratinib 180 mg qd
|
Neratinib 240 mg
Neratinib 240 mg qd
|
Neratinib 320 mg
Neratinib 320 mg qd.
|
Neratinib 400 mg
Neratinib 400 mg qd
|
|---|---|---|---|---|---|---|---|
|
Objective Response Rate
|
32.0 percentage of participants
Interval 14.9 to 53.5
|
0 percentage of participants
0%, no calculation of CI
|
13.3 percentage of participants
Interval 5.9 to 24.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose date to progression/death or last assessment, up to 39 weeks.Population: Breast, Lung and other solid tumors included in the efficacy evaluable population
Patients with PR or higher responses or SD\>=24 weeks, evaluable population
Outcome measures
| Measure |
Neratinib 40 mg
n=25 Participants
Neratinb 40 mg qd
|
Neratinib 80 mg
n=14 Participants
Neratinib 80 mg qd
|
Neratinib 120 mg
n=60 Participants
Neratinib 120 mg qd
|
Neratinib 180 mg
Neratinib 180 mg qd
|
Neratinib 240 mg
Neratinib 240 mg qd
|
Neratinib 320 mg
Neratinib 320 mg qd.
|
Neratinib 400 mg
Neratinib 400 mg qd
|
|---|---|---|---|---|---|---|---|
|
Clinical Benefit Rate
|
36.0 percentage of participants
Interval 18.0 to 57.5
|
42.9 percentage of participants
Interval 17.7 to 71.1
|
25.0 percentage of participants
Interval 14.7 to 37.9
|
—
|
—
|
—
|
—
|
Adverse Events
Neratinib 40 mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Neratinib 80 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Neratinib 120 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Neratinib 180 mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Neratinib 240 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Neratinib 320 mg
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Neratinib 400 mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Neratinib MTD
Serious events: 14 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Neratinib 40 mg
n=3 participants at risk
Neratinb 40 mg qd
|
Neratinib 80 mg
n=4 participants at risk
Neratinib 80 mg qd
|
Neratinib 120 mg
n=4 participants at risk
Neratinib 120 mg qd
|
Neratinib 180 mg
n=6 participants at risk
Neratinib 180 mg qd
|
Neratinib 240 mg
n=3 participants at risk
Neratinib 240 mg qd
|
Neratinib 320 mg
n=7 participants at risk
Neratinib 320 mg qd
|
Neratinib 400 mg
n=6 participants at risk
Neratinib 400 mg qd
|
Neratinib MTD
n=39 participants at risk
Neratinib maximum tolerated dose (320 mg).
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Cardiac disorders
Tachycardia
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Eye disorders
Papilloedema
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
General disorders
Asthenia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
General disorders
Chest pain
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Infections and infestations
Viral infection
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
2/6 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
2/6 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
66.7%
2/3 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 5 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
Other adverse events
| Measure |
Neratinib 40 mg
n=3 participants at risk
Neratinb 40 mg qd
|
Neratinib 80 mg
n=4 participants at risk
Neratinib 80 mg qd
|
Neratinib 120 mg
n=4 participants at risk
Neratinib 120 mg qd
|
Neratinib 180 mg
n=6 participants at risk
Neratinib 180 mg qd
|
Neratinib 240 mg
n=3 participants at risk
Neratinib 240 mg qd
|
Neratinib 320 mg
n=7 participants at risk
Neratinib 320 mg qd
|
Neratinib 400 mg
n=6 participants at risk
Neratinib 400 mg qd
|
Neratinib MTD
n=39 participants at risk
Neratinib maximum tolerated dose (320 mg).
|
|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
28.6%
2/7 • Number of events 10 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
12.8%
5/39 • Number of events 20 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
2/6 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
50.0%
2/4 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 6 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
2/6 • Number of events 9 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Cardiac disorders
Bundle branch block left
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Cardiac disorders
Supraventricular tachycardia
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Cardiac disorders
Tachycardia
|
66.7%
2/3 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Eye disorders
Corneal opacity
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Eye disorders
Diplopia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Eye disorders
Photopsia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Abdominal distension
|
66.7%
2/3 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
7.7%
3/39 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
2/3 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
57.1%
4/7 • Number of events 6 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
20.5%
8/39 • Number of events 17 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
28.6%
2/7 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
7.7%
3/39 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
50.0%
2/4 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
2/6 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
12.8%
5/39 • Number of events 7 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
50.0%
2/4 • Number of events 5 • From first dose through 28 days after last dose, up to 39 weeks.
|
75.0%
3/4 • Number of events 13 • From first dose through 28 days after last dose, up to 39 weeks.
|
100.0%
6/6 • Number of events 26 • From first dose through 28 days after last dose, up to 39 weeks.
|
100.0%
3/3 • Number of events 19 • From first dose through 28 days after last dose, up to 39 weeks.
|
100.0%
7/7 • Number of events 26 • From first dose through 28 days after last dose, up to 39 weeks.
|
83.3%
5/6 • Number of events 35 • From first dose through 28 days after last dose, up to 39 weeks.
|
92.3%
36/39 • Number of events 189 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
10.3%
4/39 • Number of events 5 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
66.7%
2/3 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
7.7%
3/39 • Number of events 5 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
7.7%
3/39 • Number of events 6 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
10.3%
4/39 • Number of events 5 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Gastritis
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Haematochezia
|
33.3%
1/3 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Haemorrhoids
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
75.0%
3/4 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
100.0%
4/4 • Number of events 12 • From first dose through 28 days after last dose, up to 39 weeks.
|
50.0%
3/6 • Number of events 11 • From first dose through 28 days after last dose, up to 39 weeks.
|
100.0%
3/3 • Number of events 7 • From first dose through 28 days after last dose, up to 39 weeks.
|
71.4%
5/7 • Number of events 16 • From first dose through 28 days after last dose, up to 39 weeks.
|
100.0%
6/6 • Number of events 16 • From first dose through 28 days after last dose, up to 39 weeks.
|
53.8%
21/39 • Number of events 47 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Oesophagitis
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Toothache
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
50.0%
2/4 • Number of events 6 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
2/6 • Number of events 5 • From first dose through 28 days after last dose, up to 39 weeks.
|
66.7%
2/3 • Number of events 11 • From first dose through 28 days after last dose, up to 39 weeks.
|
42.9%
3/7 • Number of events 8 • From first dose through 28 days after last dose, up to 39 weeks.
|
100.0%
6/6 • Number of events 12 • From first dose through 28 days after last dose, up to 39 weeks.
|
48.7%
19/39 • Number of events 43 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
General disorders
Asthenia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
28.6%
2/7 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 7 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
General disorders
Axillary pain
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
General disorders
Chest pain
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
General disorders
Chills
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
50.0%
2/4 • Number of events 7 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
2/6 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
28.6%
2/7 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
General disorders
Early satiety
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
General disorders
Face oedema
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 7 • From first dose through 28 days after last dose, up to 39 weeks.
|
75.0%
3/4 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
75.0%
3/4 • Number of events 6 • From first dose through 28 days after last dose, up to 39 weeks.
|
66.7%
4/6 • Number of events 5 • From first dose through 28 days after last dose, up to 39 weeks.
|
66.7%
2/3 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
85.7%
6/7 • Number of events 13 • From first dose through 28 days after last dose, up to 39 weeks.
|
83.3%
5/6 • Number of events 11 • From first dose through 28 days after last dose, up to 39 weeks.
|
48.7%
19/39 • Number of events 47 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
General disorders
Local swelling
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
General disorders
Localised oedema
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
General disorders
Malaise
|
33.3%
1/3 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
7.7%
3/39 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
General disorders
Oedema
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
General disorders
Oedema peripheral
|
66.7%
2/3 • Number of events 5 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
10.3%
4/39 • Number of events 9 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
General disorders
Pain
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
General disorders
Performance status decreased
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
7.7%
3/39 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
28.6%
2/7 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Infections and infestations
Nail bed infection
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
2/6 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
7.7%
3/39 • Number of events 8 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
2/6 • Number of events 11 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
15.4%
6/39 • Number of events 15 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
50.0%
3/6 • Number of events 8 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
15.4%
6/39 • Number of events 9 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
2/6 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
28.6%
2/7 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
17.9%
7/39 • Number of events 9 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Investigations
Blood chloride decreased
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 6 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Investigations
Blood urea increased
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Investigations
Electrocardiogram ST-T segment abnormal
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
2/6 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
28.6%
2/7 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
2/6 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
17.9%
7/39 • Number of events 16 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Investigations
Weight increased
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
75.0%
3/4 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 5 • From first dose through 28 days after last dose, up to 39 weeks.
|
100.0%
3/3 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
71.4%
5/7 • Number of events 7 • From first dose through 28 days after last dose, up to 39 weeks.
|
50.0%
3/6 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
43.6%
17/39 • Number of events 36 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
15.4%
6/39 • Number of events 7 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
66.7%
2/3 • Number of events 5 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 5 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
66.7%
2/3 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
7.7%
3/39 • Number of events 6 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 6 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
15.4%
6/39 • Number of events 24 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
2/6 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
28.6%
2/7 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
7.7%
3/39 • Number of events 7 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 5 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 5 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
7.7%
3/39 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
66.7%
2/3 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 12 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
7.7%
3/39 • Number of events 5 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
15.4%
6/39 • Number of events 13 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
66.7%
2/3 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
23.1%
9/39 • Number of events 19 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
50.0%
2/4 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Nervous system disorders
Migraine
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
28.6%
2/7 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Psychiatric disorders
Depression
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
50.0%
2/4 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
7.7%
3/39 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 6 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Reproductive system and breast disorders
Breast swelling
|
33.3%
1/3 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Reproductive system and breast disorders
Penile swelling
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Reproductive system and breast disorders
Scrotal swelling
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
2/6 • Number of events 6 • From first dose through 28 days after last dose, up to 39 weeks.
|
23.1%
9/39 • Number of events 15 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
66.7%
2/3 • Number of events 6 • From first dose through 28 days after last dose, up to 39 weeks.
|
50.0%
2/4 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
50.0%
2/4 • Number of events 5 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
28.6%
2/7 • Number of events 6 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
2/6 • Number of events 8 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.6%
10/39 • Number of events 14 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
33.3%
1/3 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
7.7%
3/39 • Number of events 5 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
66.7%
2/3 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
5.1%
2/39 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
7.7%
3/39 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
33.3%
1/3 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
7.7%
3/39 • Number of events 3 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
42.9%
3/7 • Number of events 4 • From first dose through 28 days after last dose, up to 39 weeks.
|
33.3%
2/6 • Number of events 7 • From first dose through 28 days after last dose, up to 39 weeks.
|
7.7%
3/39 • Number of events 10 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
2.6%
1/39 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
14.3%
1/7 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
33.3%
1/3 • Number of events 1 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
16.7%
1/6 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
25.0%
1/4 • Number of events 2 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/3 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to 39 weeks.
|
0.00%
0/39 • From first dose through 28 days after last dose, up to 39 weeks.
|
Additional Information
Senior Director, Clinical Operations
Puma Biotechnology, Inc.
Phone: +1 (424) 248-6500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60