Trial Outcomes & Findings for Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer (NCT NCT00741260)
NCT ID: NCT00741260
Last Updated: 2018-09-05
Results Overview
Number of participants reporting Adverse Events Causing Dose Limiting Toxicities (DLT).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
105 participants
Primary outcome timeframe
From first dose date to day 21
Results posted on
2018-09-05
Participant Flow
Participant milestones
| Measure |
N160 + C1500
Neratinib 160 mg + Capecitabine 1500 mg/sq m
|
N240 + C1500
Neratinib 240 mg + Capecitabine 1500 mg/sq m
|
N240 + C2000
Neratinib 240 mg + Capecitabine 2000 mg/sq m
|
N200 + C2000
Neratinib 200 mg + Capecitabine 2000 mg/sq m
|
N160 + C2000
Neratinib 160 mg + Capecitabine 2000 mg/sq m
|
N + C MTD - No Prior Lap
Neratinib + Capecitabine MTD (No prior Lapatinib)
|
N + C MTD - Prior Lap
Neratinib + Capecitabine MTD (Prior Lapatinib)
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
4
|
6
|
9
|
65
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
20
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
4
|
6
|
9
|
45
|
7
|
Reasons for withdrawal
| Measure |
N160 + C1500
Neratinib 160 mg + Capecitabine 1500 mg/sq m
|
N240 + C1500
Neratinib 240 mg + Capecitabine 1500 mg/sq m
|
N240 + C2000
Neratinib 240 mg + Capecitabine 2000 mg/sq m
|
N200 + C2000
Neratinib 200 mg + Capecitabine 2000 mg/sq m
|
N160 + C2000
Neratinib 160 mg + Capecitabine 2000 mg/sq m
|
N + C MTD - No Prior Lap
Neratinib + Capecitabine MTD (No prior Lapatinib)
|
N + C MTD - Prior Lap
Neratinib + Capecitabine MTD (Prior Lapatinib)
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Disease Progression
|
3
|
5
|
3
|
3
|
5
|
37
|
4
|
|
Overall Study
Death
|
0
|
1
|
0
|
1
|
2
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
3
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
2
|
1
|
1
|
2
|
1
|
3
|
1
|
Baseline Characteristics
Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer
Baseline characteristics by cohort
| Measure |
N160 + C1500
n=6 Participants
Neratinib 160 mg + Capecitabine 1500 mg/sq m
|
N240 + C1500
n=8 Participants
Neratinib 240 mg + Capecitabine 1500 mg/sq m
|
N240 + C2000
n=4 Participants
Neratinib 240 mg + Capecitabine 2000 mg/sq m
|
N200 + C2000
n=6 Participants
Neratinib 200 mg + Capecitabine 2000 mg/sq m
|
N160 + C2000
n=9 Participants
Neratinib 160 mg + Capecitabine 2000 mg/sq m
|
N + C MTD - No Prior Lap
n=65 Participants
Neratinib + Capecitabine MTD (No prior Lapatinib)
|
N + C MTD - Prior Lap
n=7 Participants
Neratinib + Capecitabine MTD (Prior Lapatinib)
|
Total
n=105 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
59 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
91 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
14 Participants
n=6 Participants
|
|
Age, Continuous
|
49.7 years
STANDARD_DEVIATION 11.50 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 10.42 • n=7 Participants
|
56.3 years
STANDARD_DEVIATION 17.15 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 10.88 • n=4 Participants
|
55.7 years
STANDARD_DEVIATION 10.64 • n=21 Participants
|
51.5 years
STANDARD_DEVIATION 10.48 • n=10 Participants
|
50.9 years
STANDARD_DEVIATION 10.65 • n=115 Participants
|
52.4 years
STANDARD_DEVIATION 10.77 • n=6 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
65 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
93 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
12 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
25 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
28 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
38 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
74 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: From first dose date to day 21Population: Safety population
Number of participants reporting Adverse Events Causing Dose Limiting Toxicities (DLT).
Outcome measures
| Measure |
N160 + C1500
n=6 Participants
Neratinib 160 mg + Capecitabine 1500 mg/m2
|
N160 + C2000
n=9 Participants
Neratinib 160 mg + Capecitabine 2000 mg/m2
|
N200 + C2000
n=6 Participants
Neratinib 200 mg + Capecitabine 2000 mg/m2
|
N240 + C1500
n=8 Participants
Neratinib 240 mg + Capecitabine 1500 mg/m2
|
N240 + C2000
n=4 Participants
Neratinib 240 mg + Capecitabine 2000 mg/m2
|
N + C MTD - No Prior Lap
n=65 Participants
Neratinib + Capecitabine MTD (No prior Lapatinib)
|
N + C MTD - Prior Lap
n=7 Participants
Neratinib + Capecitabine MTD (Prior Lapatinib)
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose date to day 21.Population: All patients in the safety population in part 1 (dose-escalation) of the study.
MTD reflects the highest dose of neratinib plus capeciteabine that did not cause a selected Grade 3 toxicity in \>= 2 participants, which is any of 1) Grade 3 or 4 non-hematologic toxicity (Grade 3 asthenia was not considered a DLT unless lasting \>3 days, 2) Grade 3 diarrhea lasting \>2 days on optimal medical therapy or associated with fever or dehydration. 3) Grade 4 neutropenia lasting ≥ 3 days or Grade 4 febrile neutropenia, 4) Grade 4 thrombocytopenia lasting ≥3 days or associated with bleeding or requiring platelet transfusion, 5) Delayed recovery \[to ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline\] from one of the above listed toxicities that were related to neratinib and/or capecitabine that delayed the initiation of the next dose by more than 3 weeks.
Outcome measures
| Measure |
N160 + C1500
n=33 Participants
Neratinib 160 mg + Capecitabine 1500 mg/m2
|
N160 + C2000
Neratinib 160 mg + Capecitabine 2000 mg/m2
|
N200 + C2000
Neratinib 200 mg + Capecitabine 2000 mg/m2
|
N240 + C1500
Neratinib 240 mg + Capecitabine 1500 mg/m2
|
N240 + C2000
Neratinib 240 mg + Capecitabine 2000 mg/m2
|
N + C MTD - No Prior Lap
Neratinib + Capecitabine MTD (No prior Lapatinib)
|
N + C MTD - Prior Lap
Neratinib + Capecitabine MTD (Prior Lapatinib)
|
|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Neratinib
|
240 mg
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose date to day 21.Population: All patients in the safety population in part 1 (dose-escalation) of the study.
MTD reflects the highest dose of capecitabine in combination with neratinib that did not cause a selected Grade 3 toxicity in \>= 2 participants, which is any of 1) Grade 3 or 4 non-hematologic toxicity (Grade 3 asthenia was not considered a DLT unless lasting \>3 days, 2) Grade 3 diarrhea lasting \>2 days on optimal medical therapy or associated with fever or dehydration. 3) Grade 4 neutropenia lasting ≥ 3 days or Grade 4 febrile neutropenia, 4) Grade 4 thrombocytopenia lasting ≥3 days or associated with bleeding or requiring platelet transfusion, 5) Delayed recovery \[to ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline\] from one of the above listed toxicities that were related to neratinib and/or capecitabine that delayed the initiation of the next dose by more than 3 weeks.
Outcome measures
| Measure |
N160 + C1500
n=33 Participants
Neratinib 160 mg + Capecitabine 1500 mg/m2
|
N160 + C2000
Neratinib 160 mg + Capecitabine 2000 mg/m2
|
N200 + C2000
Neratinib 200 mg + Capecitabine 2000 mg/m2
|
N240 + C1500
Neratinib 240 mg + Capecitabine 1500 mg/m2
|
N240 + C2000
Neratinib 240 mg + Capecitabine 2000 mg/m2
|
N + C MTD - No Prior Lap
Neratinib + Capecitabine MTD (No prior Lapatinib)
|
N + C MTD - Prior Lap
Neratinib + Capecitabine MTD (Prior Lapatinib)
|
|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Capecitabine
|
1500 mg/m^2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose date to progression or last tumor assessment, up to three years.Population: Evaluable Population includes subjects who met all inclusion/exclusion criteria, received at least two weeks of neratinib and capecitabine, and underwent valid tumor assessments at baseline and at least one post-baseline time point stratified by prior Lapatinib exposure.
Number of Subjects with Complete or Partial Response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.
Outcome measures
| Measure |
N160 + C1500
n=7 Participants
Neratinib 160 mg + Capecitabine 1500 mg/m2
|
N160 + C2000
n=61 Participants
Neratinib 160 mg + Capecitabine 2000 mg/m2
|
N200 + C2000
n=63 Participants
Neratinib 200 mg + Capecitabine 2000 mg/m2
|
N240 + C1500
Neratinib 240 mg + Capecitabine 1500 mg/m2
|
N240 + C2000
Neratinib 240 mg + Capecitabine 2000 mg/m2
|
N + C MTD - No Prior Lap
Neratinib + Capecitabine MTD (No prior Lapatinib)
|
N + C MTD - Prior Lap
Neratinib + Capecitabine MTD (Prior Lapatinib)
|
|---|---|---|---|---|---|---|---|
|
Overall Response Rate
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
63.9 percentage of participants
Interval 50.6 to 75.8
|
63.5 percentage of participants
Interval 50.4 to 75.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose date to progression or last tumor assessment, up to three years.Population: Evaluable Population includes subjects who met all inclusion/exclusion criteria, received at least two weeks of neratinib and capecitabine, and underwent valid tumor assessments at baseline and at least one post-baseline time point stratified by prior Lapatinib exposure.
The percentage of subjects with Complete Response, Partial Response, or Stable Disease at least 24 weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
N160 + C1500
n=7 Participants
Neratinib 160 mg + Capecitabine 1500 mg/m2
|
N160 + C2000
n=61 Participants
Neratinib 160 mg + Capecitabine 2000 mg/m2
|
N200 + C2000
n=63 Participants
Neratinib 200 mg + Capecitabine 2000 mg/m2
|
N240 + C1500
Neratinib 240 mg + Capecitabine 1500 mg/m2
|
N240 + C2000
Neratinib 240 mg + Capecitabine 2000 mg/m2
|
N + C MTD - No Prior Lap
Neratinib + Capecitabine MTD (No prior Lapatinib)
|
N + C MTD - Prior Lap
Neratinib + Capecitabine MTD (Prior Lapatinib)
|
|---|---|---|---|---|---|---|---|
|
Clinical Benefit Rate
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
72.1 percentage of participants
Interval 59.2 to 82.9
|
73.0 percentage of participants
Interval 60.3 to 83.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start date of response to first PD/death, up to three years.Population: Evaluable Population includes subjects who met all inclusion/exclusion criteria, received at least two weeks of neratinib and capecitabine, and underwent valid tumor assessments at baseline and at least one post-baseline time point stratified by prior Lapatinib exposure.
Duration of response was measured from the time at which response criteria were met for complete response (CR) or partial response (PR) (whichever status was recorded first) until the first date of recurrence or progressive disease (PD) or death per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
N160 + C1500
n=4 Participants
Neratinib 160 mg + Capecitabine 1500 mg/m2
|
N160 + C2000
n=39 Participants
Neratinib 160 mg + Capecitabine 2000 mg/m2
|
N200 + C2000
n=40 Participants
Neratinib 200 mg + Capecitabine 2000 mg/m2
|
N240 + C1500
Neratinib 240 mg + Capecitabine 1500 mg/m2
|
N240 + C2000
Neratinib 240 mg + Capecitabine 2000 mg/m2
|
N + C MTD - No Prior Lap
Neratinib + Capecitabine MTD (No prior Lapatinib)
|
N + C MTD - Prior Lap
Neratinib + Capecitabine MTD (Prior Lapatinib)
|
|---|---|---|---|---|---|---|---|
|
Duration of Response
|
48.3 weeks
Interval 30.0 to 61.0
|
46.3 weeks
Interval 30.1 to
Upper limit of the 95% confidence interval not estimable due to insufficient number of participants with events.
|
46.3 weeks
Interval 30.1 to
Upper limit of the 95% confidence interval not estimable due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
Adverse Events
N160 + C1500
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
N240 + C1500
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
N240 + C2000
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
N200 + C2000
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
N160 + C2000
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
N + C MTD - No Prior Lap
Serious events: 19 serious events
Other events: 62 other events
Deaths: 0 deaths
N + C MTD - Prior Lap
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
N160 + C1500
n=6 participants at risk
Neratinib 160 mg + Capecitabine 1500 mg/m2
|
N240 + C1500
n=8 participants at risk
Neratinib 240 mg + Capecitabine 1500 mg/m2
|
N240 + C2000
n=4 participants at risk
Neratinib 240 mg + Capecitabine 2000 mg/m2
|
N200 + C2000
n=6 participants at risk
Neratinib 200 mg + Capecitabine 2000 mg/m2
|
N160 + C2000
n=9 participants at risk
Neratinib 160 mg + Capecitabine 2000 mg/m2
|
N + C MTD - No Prior Lap
n=65 participants at risk
Neratinib + Capecitabine MTD (No prior Lapatinib)
|
N + C MTD - Prior Lap
n=7 participants at risk
Neratinib + Capecitabine MTD (Prior Lapatinib)
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Cardiac disorders
Pericardial effusion
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
28.6%
2/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
General disorders
Chills
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
General disorders
Disease progression
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
3.1%
2/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
General disorders
General physical health deterioration
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
General disorders
Pain
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
General disorders
Pyrexia
|
33.3%
2/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Hepatobiliary disorders
Biloma
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Infections and infestations
Cystitis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Investigations
Blood alkaline phosphatase abnormal
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
28.6%
2/7 • From first dose through 28 days after last dose, up to five years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Nervous system disorders
Nerve root compression
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Renal and urinary disorders
Calculus ureteric
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Renal and urinary disorders
Haematuria
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
Other adverse events
| Measure |
N160 + C1500
n=6 participants at risk
Neratinib 160 mg + Capecitabine 1500 mg/m2
|
N240 + C1500
n=8 participants at risk
Neratinib 240 mg + Capecitabine 1500 mg/m2
|
N240 + C2000
n=4 participants at risk
Neratinib 240 mg + Capecitabine 2000 mg/m2
|
N200 + C2000
n=6 participants at risk
Neratinib 200 mg + Capecitabine 2000 mg/m2
|
N160 + C2000
n=9 participants at risk
Neratinib 160 mg + Capecitabine 2000 mg/m2
|
N + C MTD - No Prior Lap
n=65 participants at risk
Neratinib + Capecitabine MTD (No prior Lapatinib)
|
N + C MTD - Prior Lap
n=7 participants at risk
Neratinib + Capecitabine MTD (Prior Lapatinib)
|
|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
50.0%
4/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
13.8%
9/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
6.2%
4/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
4.6%
3/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
9.2%
6/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Blood and lymphatic system disorders
Leukopenia
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
6.2%
4/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
3.1%
2/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
22.2%
2/9 • From first dose through 28 days after last dose, up to five years.
|
16.9%
11/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
33.3%
2/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Cardiac disorders
Tachycardia
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
6.2%
4/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
3.1%
2/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
33.3%
2/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
25.0%
2/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
33.3%
2/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
12.3%
8/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
7.7%
5/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
3.1%
2/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
25.0%
2/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
12.3%
8/65 • From first dose through 28 days after last dose, up to five years.
|
28.6%
2/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Diarrhoea
|
83.3%
5/6 • From first dose through 28 days after last dose, up to five years.
|
87.5%
7/8 • From first dose through 28 days after last dose, up to five years.
|
100.0%
4/4 • From first dose through 28 days after last dose, up to five years.
|
100.0%
6/6 • From first dose through 28 days after last dose, up to five years.
|
88.9%
8/9 • From first dose through 28 days after last dose, up to five years.
|
90.8%
59/65 • From first dose through 28 days after last dose, up to five years.
|
100.0%
7/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
4.6%
3/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
25.0%
2/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
16.9%
11/65 • From first dose through 28 days after last dose, up to five years.
|
28.6%
2/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
3.1%
2/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • From first dose through 28 days after last dose, up to five years.
|
50.0%
4/8 • From first dose through 28 days after last dose, up to five years.
|
50.0%
2/4 • From first dose through 28 days after last dose, up to five years.
|
50.0%
3/6 • From first dose through 28 days after last dose, up to five years.
|
33.3%
3/9 • From first dose through 28 days after last dose, up to five years.
|
38.5%
25/65 • From first dose through 28 days after last dose, up to five years.
|
57.1%
4/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
18.5%
12/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
75.0%
6/8 • From first dose through 28 days after last dose, up to five years.
|
50.0%
2/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
33.3%
3/9 • From first dose through 28 days after last dose, up to five years.
|
32.3%
21/65 • From first dose through 28 days after last dose, up to five years.
|
42.9%
3/7 • From first dose through 28 days after last dose, up to five years.
|
|
General disorders
Asthenia
|
33.3%
2/6 • From first dose through 28 days after last dose, up to five years.
|
50.0%
4/8 • From first dose through 28 days after last dose, up to five years.
|
50.0%
2/4 • From first dose through 28 days after last dose, up to five years.
|
33.3%
2/6 • From first dose through 28 days after last dose, up to five years.
|
55.6%
5/9 • From first dose through 28 days after last dose, up to five years.
|
18.5%
12/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
General disorders
Chills
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
General disorders
Early satiety
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
General disorders
Fatigue
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
37.5%
3/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
44.4%
4/9 • From first dose through 28 days after last dose, up to five years.
|
23.1%
15/65 • From first dose through 28 days after last dose, up to five years.
|
28.6%
2/7 • From first dose through 28 days after last dose, up to five years.
|
|
General disorders
Impaired healing
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
General disorders
Implant site pain
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
General disorders
Inflammation
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
9.2%
6/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
General disorders
Injection site extravasation
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
37.5%
3/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
33.3%
2/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
13.8%
9/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
General disorders
Oedema
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
3.1%
2/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
3.1%
2/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
General disorders
Pain
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
22.2%
2/9 • From first dose through 28 days after last dose, up to five years.
|
4.6%
3/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
General disorders
Pyrexia
|
33.3%
2/6 • From first dose through 28 days after last dose, up to five years.
|
25.0%
2/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
22.2%
2/9 • From first dose through 28 days after last dose, up to five years.
|
9.2%
6/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
General disorders
Xerosis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
3.1%
2/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Infections and infestations
Candida infection
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Infections and infestations
Gastroenteritis
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Infections and infestations
Nail infection
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
4.6%
3/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
7.7%
5/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Infections and infestations
Paronychia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
12.3%
8/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
3.1%
2/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
6.2%
4/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
22.2%
2/9 • From first dose through 28 days after last dose, up to five years.
|
13.8%
9/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
6.2%
4/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Infections and infestations
Wound infection pseudomonas
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Injury, poisoning and procedural complications
Periorbital contusion
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
33.3%
2/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
22.2%
2/9 • From first dose through 28 days after last dose, up to five years.
|
16.9%
11/65 • From first dose through 28 days after last dose, up to five years.
|
28.6%
2/7 • From first dose through 28 days after last dose, up to five years.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
2/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
22.2%
2/9 • From first dose through 28 days after last dose, up to five years.
|
15.4%
10/65 • From first dose through 28 days after last dose, up to five years.
|
28.6%
2/7 • From first dose through 28 days after last dose, up to five years.
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
33.3%
3/9 • From first dose through 28 days after last dose, up to five years.
|
4.6%
3/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
9.2%
6/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
3.1%
2/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Investigations
Blood glucose increased
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
4.6%
3/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
9.2%
6/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Investigations
Gamma-glutamyltransferase increased
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
22.2%
2/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
4.6%
3/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Investigations
International normalised ratio increased
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Investigations
Liver function test abnormal
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Investigations
Weight decreased
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
10.8%
7/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Investigations
Weight increased
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
25.0%
2/8 • From first dose through 28 days after last dose, up to five years.
|
75.0%
3/4 • From first dose through 28 days after last dose, up to five years.
|
66.7%
4/6 • From first dose through 28 days after last dose, up to five years.
|
22.2%
2/9 • From first dose through 28 days after last dose, up to five years.
|
29.2%
19/65 • From first dose through 28 days after last dose, up to five years.
|
28.6%
2/7 • From first dose through 28 days after last dose, up to five years.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
37.5%
3/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
4.6%
3/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
7.7%
5/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
4.6%
3/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
7.7%
5/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
37.5%
3/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
10.8%
7/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
7.7%
5/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
10.8%
7/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
6.2%
4/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
3.1%
2/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
12.3%
8/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Musculoskeletal and connective tissue disorders
Posture abnormal
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
37.5%
3/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
10.8%
7/65 • From first dose through 28 days after last dose, up to five years.
|
28.6%
2/7 • From first dose through 28 days after last dose, up to five years.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
6.2%
4/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
22.2%
2/9 • From first dose through 28 days after last dose, up to five years.
|
18.5%
12/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
7.7%
5/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
9.2%
6/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
3.1%
2/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
4.6%
3/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Reproductive system and breast disorders
Breast swelling
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
6.2%
4/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
33.3%
3/9 • From first dose through 28 days after last dose, up to five years.
|
15.4%
10/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
7.7%
5/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
3.1%
2/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
25.0%
2/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
33.3%
2/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
10.8%
7/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
11.1%
1/9 • From first dose through 28 days after last dose, up to five years.
|
3.1%
2/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
6.2%
4/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
25.0%
2/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
4.6%
3/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
33.3%
2/6 • From first dose through 28 days after last dose, up to five years.
|
25.0%
2/8 • From first dose through 28 days after last dose, up to five years.
|
75.0%
3/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
44.4%
4/9 • From first dose through 28 days after last dose, up to five years.
|
63.1%
41/65 • From first dose through 28 days after last dose, up to five years.
|
71.4%
5/7 • From first dose through 28 days after last dose, up to five years.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
25.0%
2/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
20.0%
13/65 • From first dose through 28 days after last dose, up to five years.
|
28.6%
2/7 • From first dose through 28 days after last dose, up to five years.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
12.5%
1/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
25.0%
1/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/65 • From first dose through 28 days after last dose, up to five years.
|
14.3%
1/7 • From first dose through 28 days after last dose, up to five years.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
22.2%
2/9 • From first dose through 28 days after last dose, up to five years.
|
4.6%
3/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
1.5%
1/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/8 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/4 • From first dose through 28 days after last dose, up to five years.
|
16.7%
1/6 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/9 • From first dose through 28 days after last dose, up to five years.
|
7.7%
5/65 • From first dose through 28 days after last dose, up to five years.
|
0.00%
0/7 • From first dose through 28 days after last dose, up to five years.
|
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